Large

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.

Science & Healthcare

Fortrea

Healthcare

You need independent monitoring experience, a focus on oncology, and exposure to diverse protocols. Expect 8+ on-site days/month across the UK using a remote-based, risk-based monitoring model.

You will conduct national monitoring for oncology studies, manage multiple protocols, utilize risk-based monitoring, and complete 8+ on-site days monthly across various therapeutic areas.

Research & Development

Reading

Our Clinical Operations team in the UK is looking for a passionate CRAI with previous independent monitoring experience to work across a diverse range of therapeutic areas - including Oncology. This is your chance to gain hands-on experience in groundbreaking clinical trials while being part of a supportive, fast-paced and innovative global CRO.<br><br>What You Can Expect<br><br>✅ National monitoring across the UK (remote-based)<br><br>✅ Oncology focus, including solid tumor studies, Prostate, NSCLC, Leukemia, Breast, Glioblastoma & Hematological Malignancies<br><br>✅ Exposure to multiple protocols across Neuroscience, Cell/Gene Therapies, Respiratory, Cardiovascular, Infectious Disease, Nephrology, Endocrinology & Gastroenterology<br><br>✅ Risk-based monitoring model for smarter trial management<br><br>✅ 8+ on-site days per month<br><br>At our global CRO, we blend 30 years of expertise with innovation, offering:<br><br>🌟 Personalized development plans & career progression<br><br>🌟 A supportive environment with flexible Line Managers<br><br>🌟 Exciting collaborations with biotech & biopharma pioneers<br><br>Make a real impact in clinical research while building your career with a company that invests in your growth and success!<br><br>Ready to make a difference? Let’s connect!<br><br>Learn more about our EEO & Accommodations request here.

Our Clinical Operations team in the UK is looking for a passionate CRAI with previous independent monitoring experience to work across a diverse range of therapeutic areas - including Oncology. This is your chance to gain hands-on experience in groundbreaking clinical trials while being part of a supportive, fast-paced and innovative global CRO.What You Can Expect✅ National monitoring across the UK (remote-based)✅ Oncology focus, including solid tumor studies, Prostate, NSCLC, Leukemia, Breast, Glioblastoma & Hematological Malignancies✅ Exposure to multiple protocols across Neuroscience, Cell/Gene Therapies, Respiratory, Cardiovascular, Infectious Disease, Nephrology, Endocrinology & Gastroenterology✅ Risk-based monitoring model for smarter trial management✅ 8+ on-site days per monthAt our global CRO, we blend 30 years of expertise with innovation, offering:🌟 Personalized development plans & career progression🌟 A supportive environment with flexible Line Managers🌟 Exciting collaborations with biotech & biopharma pioneersMake a real impact in clinical research while building your career with a company that invests in your growth and success!Ready to make a difference? Let’s connect!Learn more about our EEO & Accommodations request here.

Clinical Research Associate I - Fortrea

Our &lt;strong&gt;Clinical Operations&lt;/strong&gt; team in the UK is looking for a passionate &lt;strong&gt;CRAI&lt;/strong&gt; with &lt;strong&gt;previous independent monitoring experience&lt;/strong&gt; to work across a diverse range of therapeutic areas - including &lt;strong&gt;Oncology&lt;/strong&gt;. This is your chance to gain hands-on experience in groundbreaking clinical trials while being part of a &lt;strong&gt;supportive, fast-paced and innovative&lt;/strong&gt; global CRO.&lt;br&gt;&lt;br&gt;&lt;strong&gt;What You Can Expect&lt;br&gt;&lt;br&gt;&lt;/strong&gt;✅ &lt;strong&gt;National monitoring across the UK&lt;/strong&gt; (remote-based)&lt;br&gt;&lt;br&gt;✅ &lt;strong&gt;Oncology focus&lt;/strong&gt;, including solid tumor studies, Prostate, NSCLC, Leukemia, Breast, Glioblastoma &amp;amp; Hematological Malignancies&lt;br&gt;&lt;br&gt;✅ &lt;strong&gt;Exposure to multiple protocols&lt;/strong&gt; across Neuroscience, Cell/Gene Therapies, Respiratory, Cardiovascular, Infectious Disease, Nephrology, Endocrinology &amp;amp; Gastroenterology&lt;br&gt;&lt;br&gt;✅ &lt;strong&gt;Risk-based monitoring model&lt;/strong&gt; for smarter trial management&lt;br&gt;&lt;br&gt;✅ &lt;strong&gt;8+ on-site days per month&lt;br&gt;&lt;br&gt;&lt;/strong&gt;At our &lt;strong&gt;global CRO&lt;/strong&gt;, we blend 30 years of expertise with innovation, offering:&lt;br&gt;&lt;br&gt;🌟 &lt;strong&gt;Personalized development plans &amp;amp; career progression&lt;br&gt;&lt;br&gt;&lt;/strong&gt;🌟 &lt;strong&gt;A supportive environment with flexible Line Managers&lt;br&gt;&lt;br&gt;&lt;/strong&gt;🌟 &lt;strong&gt;Exciting collaborations with biotech &amp;amp; biopharma pioneers&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Make a real impact in clinical research while building your career with a company that invests in &lt;strong&gt;your growth and success&lt;/strong&gt;!&lt;br&gt;&lt;br&gt;&lt;strong&gt;Ready to make a difference? Let’s connect!&lt;br&gt;&lt;br&gt;&lt;/strong&gt;Learn more about our EEO &amp;amp; Accommodations request here.

Clinical Research Associate I

United Kingdom

You must manage safety case intake, process adverse events, perform data entry, write narratives, assist in report submissions, ensure compliance, and maintain documentation.

You will perform case intake, process adverse events, enter data, write narratives, submit reports, assist with compliance, and maintain documentation while supporting cross-functional relationships.

Pune

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.<br><br> Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial<br><br> Assist with processing of the adverse events, including but not limited to:<br><br><br> * Data entry of safety data onto adverse event tracking systems<br> * Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)<br> * Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)<br> * Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed<br> * Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines<br>   <br>   <br>   <br><br> Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines<br><br>Assist in the reconciliation of databases, as applicable<br><br> Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate<br><br> Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable<br><br> Support upload/archival of case/study/project documentation, as appropriate<br><br> Build and maintain good PSS relationships across functional units<br><br> Support compliance of operations with governing regulatory requirements<br><br> Any other duties as assigned by management<br><br><br> * The above job duties are completed by the staff as applicable, depending on the role they are assigned to.<br>   <br>   <br>   <br><br>Fortrea is proud to be an Equal Opportunity Employer:<br><br>As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.<br><br>For more information about how we collect and store your personal data, please see our Privacy Statement.

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*. Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial Assist with processing of the adverse events, including but not limited to: * Data entry of safety data onto adverse event tracking systems * Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable) * Assist in the listedness assessment against appropriate label (for Marketed products, if applicable) * Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed * Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines          Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelinesAssist in the reconciliation of databases, as applicable Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable Support upload/archival of case/study/project documentation, as appropriate Build and maintain good PSS relationships across functional units Support compliance of operations with governing regulatory requirements Any other duties as assigned by management * The above job duties are completed by the staff as applicable, depending on the role they are assigned to.         Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.

Safety Science Analyst - Fortrea

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.&lt;br&gt;&lt;br&gt; Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial&lt;br&gt;&lt;br&gt; Assist with processing of the adverse events, including but not limited to:&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Data entry of safety data onto adverse event tracking systems&lt;/li&gt;&lt;li&gt;Write patient narratives &amp;amp; code adverse events accurately using MedDRA (for Marketed products, if applicable)&lt;/li&gt;&lt;li&gt;Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)&lt;/li&gt;&lt;li&gt;Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed&lt;/li&gt;&lt;li&gt;Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt; Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines&lt;br&gt;&lt;br&gt;Assist in the reconciliation of databases, as applicable&lt;br&gt;&lt;br&gt; Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate&lt;br&gt;&lt;br&gt; Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable&lt;br&gt;&lt;br&gt; Support upload/archival of case/study/project documentation, as appropriate&lt;br&gt;&lt;br&gt; Build and maintain good PSS relationships across functional units&lt;br&gt;&lt;br&gt; Support compliance of operations with governing regulatory requirements&lt;br&gt;&lt;br&gt; Any other duties as assigned by management&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt; The above job duties are completed by the staff as applicable, depending on the role they are assigned to.&lt;br&gt;&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;Fortrea is proud to be an Equal Opportunity Employer:&lt;br&gt;&lt;br&gt;&lt;/strong&gt;As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.&lt;br&gt;&lt;br&gt;For more information about how we collect and store your personal data, please see our Privacy Statement.

Safety Science Analyst

You must prioritize and assign cases, maintain databases, track progress, ensure timely follow-up, reconcile data daily, and support Pharmacovigilance activities as needed.

You will prioritize and assign cases, track progress, update data sheets, reconcile metrics, and support Pharmacovigilance activities to ensure timely case processing and compliance.

Manila

<div><div>As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.</div><ul><li>Segregate cases received as per priority and due dates in the database worklist.</li><li>Assign cases to case processing team based on the priority and availability of resources in consultation with Team Lead or designee.</li><li>Enter data into the Master case tracking sheet. Track and monitor the case progression with help of case tracking sheet. Follow up with associates and/or team leads to ensure timely completion of review and ensure case prioritization.</li><li>Reconciliation of TAT data on a daily basis to ensure all the cases are assigned and reviewed as per SLA.</li><li>Ensure timely updating of productivity, QC and other role specific trackers on a real time basis and follow up with Team Leads for the same.</li><li>Daily reconciliation of received and processed cases to ensure all received cases is processed with internal timelines.</li><li>Perform any other Pharmacovigilance support activities as assigned &ndash; tracking various types of information and metrics, reconciliation of data from multiple sources.</li></ul><div>
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.</div><div></div><div>
Fortrea is proud to be an Equal Opportunity Employer:</div><div><br>
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.</div><div></div><div>
For more information about how we collect and store your personal data, please see our <div>Privacy Statement</div>.</div></div>

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Segregate cases received as per priority and due dates in the database worklist.Assign cases to case processing team based on the priority and availability of resources in consultation with Team Lead or designee.Enter data into the Master case tracking sheet. Track and monitor the case progression with help of case tracking sheet. Follow up with associates and/or team leads to ensure timely completion of review and ensure case prioritization.Reconciliation of TAT data on a daily basis to ensure all the cases are assigned and reviewed as per SLA.Ensure timely updating of productivity, QC and other role specific trackers on a real time basis and follow up with Team Leads for the same.Daily reconciliation of received and processed cases to ensure all received cases is processed with internal timelines.Perform any other Pharmacovigilance support activities as assigned – tracking various types of information and metrics, reconciliation of data from multiple sources.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.

Assistant Workflow Analyst II - Fortrea

Assistant Workflow Analyst II

You need a degree in life sciences or relevant experience in clinical research. Knowledge of ICH/GCP, drug development, and fluency in English and local language are essential.

You will ensure protocol performance, manage timelines and resources, oversee quality and compliance, collaborate with external partners, and support internal strategy alignment.

Madrid

<div>
 <div>
  As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
 </div>
 <div>
  This role is for upcoming future opportunities they may arise at Fortrea
 </div>
 <div>
  The local study manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study. Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Requires strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards. Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic, and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment. The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance, and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously. Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Client’s reputation. In collaboration with CRD, represents Client in Pharma industry issues and in seeking influence in external R&amp;D environment.
 </div>
 <div>
  Summary of Responsibilities:
 </div>
 <ul>
  <li>PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%</li>
  <li>MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%</li>
  <li>QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%</li>
  <li>EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols. 20%</li>
  <li>INTERNAL COLLABORATION &amp; STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 10%</li>
  <li>All other duties as needed or assigned.</li>
 </ul>
 <div>
  Qualifications (Minimum Required):
 </div>
 <ul>
  <li>University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.</li>
  <li>MANDATORY, In lieu of the above requirement, candidates with minimum of two or more years of relevant clinical research experience as local study manager in pharmaceutical or CRO industries or experience in a health care setting will be considered.</li>
  <li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li>
  <li>Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.</li>
  <li>Thorough understanding of the drug development process.</li>
  <li>Fluent in local office language and in English, both written and verbal.</li>
 </ul>
 <div>
  Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
 </div>
 <div></div>
 <div>
  Fortrea is proud to be an Equal Opportunity Employer:
 </div>
 <div>
  <br> As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
 </div>
 <div></div>
 <div>
  For more information about how we collect and store your personal data, please see our 
  <div>
   Privacy Statement
  </div>.
 </div>
</div>


 
  As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
 
 
  This role is for upcoming future opportunities they may arise at Fortrea
 
 
  The local study manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study. Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Requires strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards. Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic, and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment. The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance, and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously. Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Client’s reputation. In collaboration with CRD, represents Client in Pharma industry issues and in seeking influence in external R&D environment.
 
 
  Summary of Responsibilities:
 
 
  PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
  MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
  QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%
  EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols. 20%
  INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 10%
  All other duties as needed or assigned.
 
 
  Qualifications (Minimum Required):
 
 
  University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
  MANDATORY, In lieu of the above requirement, candidates with minimum of two or more years of relevant clinical research experience as local study manager in pharmaceutical or CRO industries or experience in a health care setting will be considered.
  Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
  Thorough understanding of the drug development process.
  Fluent in local office language and in English, both written and verbal.
 
 
  Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
 
 
 
  Fortrea is proud to be an Equal Opportunity Employer:
 
 
   As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
 
 
 
  For more information about how we collect and store your personal data, please see our 
  
   Privacy Statement
  .
 


Local Study Manager - FSPx Team - Home Based Madrid - Fortrea

Local Study Manager - FSPx Team - Home Based Madrid

You need 0-6 months of call center experience and a healthcare-related bachelor's degree (nursing, pharmacy, medtech, PT, Radtec).

You will respond to medical queries, record adverse reactions, manage drug safety data, support various activities, ensure data quality, and handle additional tasks as assigned.

Customer Relations

<div>
 <div>
  As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
 </div>
 <ul>
  <li>To respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc.</li>
  <li>Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over telephone calls, email, fax etc.</li>
  <li>Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up.</li>
  <li>Perform and support different activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.</li>
  <li>Assume responsibility for quality of data processed.</li>
  <li>All other duties as needed or assigned.</li>
 </ul>
 <div></div>
 <div>
  Qualifications:
 </div>
 <ul>
  <li>0 to 6 months of call center experience</li>
  <li>Healthcare-related bachelor's degree e.g. nursing, pharmacy, medtech, PT, Radtec</li>
 </ul>
 <div>
  Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
 </div>
 <div></div>
 <div>
  Fortrea is proud to be an Equal Opportunity Employer:
 </div>
 <div>
  <br> As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
 </div>
 <div></div>
 <div>
  For more information about how we collect and store your personal data, please see our 
  <div>
   Privacy Statement
  </div>.
 </div>
</div>


 
  As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
 
 
  To respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc.
  Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over telephone calls, email, fax etc.
  Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up.
  Perform and support different activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
  Assume responsibility for quality of data processed.
  All other duties as needed or assigned.
 
 
 
  Qualifications:
 
 
  0 to 6 months of call center experience
  Healthcare-related bachelor's degree e.g. nursing, pharmacy, medtech, PT, Radtec
 
 
  Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
 
 
 
  Fortrea is proud to be an Equal Opportunity Employer:
 
 
   As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
 
 
 
  For more information about how we collect and store your personal data, please see our 
  
   Privacy Statement
  .
 


Fortrea

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