Clinical Project Manager

Lightship

Oct 7

Applications are closed

Job
Full-time
Senior Level
Raleigh

Requirements

Highly developed spoken and written communication skills, excellent presentation skills
Knowledge/expertise in the applicable regulations/guidelines for, and the conduct of clinical trials (virtual/DCT trial experience preferred)
Experience using a Clinical Trial Management System (CTMS) platform or equivalent
Strong interpersonal, collaboration and time management skills
Ability to establish and maintain effective working relationships with project team members, other cross functional stakeholders, and clients
Proactive, innovative problem solver with good analytical and critical thinking skills to appropriately anticipate and manage risks before they turn into issues, as well as to identify the root cause of issues and implement solutions, escalating to management for support appropriately
Ability to influence stakeholders at all levels with confidence and adapt style to deliver messaging. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature
Able to work in a fast-paced, evolving environment
Ability to embrace and manage change, be agile and adaptable
Able to work independently with minimal guidance in an unstructured environment
Undergraduate, health-related degree OR an equivalent combination of education, training, and experience sufficient to successfully perform the key responsibilities of the job
5+ years of relevant clinical research experience and solid knowledge and understanding of clinical project / trial management
Experience working in a CRO, Site, SMO or Sponsor preferred

Responsibilities

Leading cross-functional teams and third parties/vendors to ensure successful project delivery. Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out
Acting as liaison with the client and managing client contractual, organizational and relationship needs/expectations, related to operational delivery of assigned projects
Managing project contractual deliverables and modifications, and preparing and delivering study-related updates, dashboards and reports to study teams, senior management, and sponsors / vendors / partners, including but not limited to:
Recruitment, screening, and enrollment reports
Key Performance Indicators / Metrics
Status of Deliverables
Summary of risks / issues and their mitigation / resolutions
Summary reports of data flow, protocol deviations, safety reports, and other reports as applicable
Ensuring project management systems are updated weekly to reflect accurate project status
Serving as a point of escalation for project team members
Ensuring project resources are appropriately assigned in project management system and updating forecasted project hours per resource to accurately reflect project needs. Reviewing and approving reported project hours and ensuring project team report hours appropriately and in a timely fashion
Participating in revenue forecasting and review of project actual unit/hours efficiency against budget
Identifying and managing scope changes with the client with support of the project Director (as necessary)
Ensuring Director and Client Partner are kept informed of project progress through the provision of appropriate and regular updates
Developing operational plans (including operational guidelines, manuals and project plans as needed)
Overseeing all operational aspects of assigned clinical studies in accordance with local regulations, ICH GCP guidelines, SOPs (Standard Operating Procedures), and project specific plans, including but not limited to:
Managing, reviewing, and maintaining study-related essential documents (e.g., financial disclosure forms, study manuals, etc.)
Coordinating IRB/IEC correspondence and communication, ensuring that all approvals are obtained as required
Overseeing that study supplies and equipment are procured and delivered to patients and/or sites
Organizing / ensuring that appropriate study training is delivered, and maintaining the project specific training matrix and ensuring project team compliance with project specific training
Ensuring that the necessary technological solutions are designed and configured per study specifications
Ensuring that the vendors / personnel needed for each study are prepared, available, and trained, and managing assigned vendors as necessary
Working with study monitors to address issues and provide resolutions Acting as the main point of contact for study investigator, study personnel, and sponsors / vendors / partners to ensure smooth communication and collaboration
Supporting Study Start-Up with the coordination of site contracts
Working with Legal to implement vendor contracts
Working with Quality to identify and mitigate risks
Working with Finance to ensure accurate and timely invoicing to sponsors and tracking and payment of invoices from investigators and vendors
Preparing requisite project status updates in keeping with project plans at a set cadence, and tailoring messaging as necessary for different internal and external audiences
Organizing and leading study team meetings, and meetings with sponsors / vendors / partners as applicable
Participating in the development, review, and implementation of standard operating procedures, manuals, tools, and training materials
Identifying and documenting lessons learned and best practice throughout each project, and sharing at a functional and departmental level
Supporting audits and inspections, as required
Ensuring adherence to company SOPs, policies, and guidelines at the project-level
Acting as a subject matter expert or Business Process Owner (BPO) for clinical systems, where assigned

FAQs

Do we support remote work?

Yes, we support remote work in a semi-remote hybrid format.

What are the working hours for this role?

The role anchors in standard operating hours for your geographic location but may require flexibility to accommodate different time zones, including US West Coast, US East Coast, and UK-based time zones.

What is the duration of the Clinical Project Manager position?

The position is for a duration of 6 months.

Is travel required for this job?

Yes, this role requires travel during working hours, with occasional overnight travel estimated at about 30%.

What qualifications are necessary for this position?

Applicants should have an undergraduate health-related degree or equivalent experience, along with 5+ years of relevant clinical research experience and a solid understanding of clinical project/trial management.

Is virtual clinical trial experience preferred?

Yes, experience with virtual or decentralized clinical trials (DCT) is preferred.

What kind of benefits does Lightship offer?

Lightship offers a generous benefits package, including healthcare (medical, dental, and vision), a 401(k) company match, a company-provided laptop, internet and phone stipends, short & long-term disability, life insurance, and more.

What is the salary range for this role?

The base salary range for this role is between $110,000 and $145,000 (annualized), depending on education, skills, and experience.

Are COVID-19 vaccinations required for this role?

Yes, vaccination against COVID-19 is required for all positions that involve travel, in-person participation, or are patient-facing.

How does Lightship approach diversity and inclusion in the workplace?

Lightship is an equal opportunity employer that promotes a diverse and inclusive workplace, considering all applicants without regard to various protected statuses.

Lightship

Bringing recreational vehicles into the electric age

Automotive

Industry

51-200

Employees

2020

Founded Year

Mission & Purpose

Lightship is an early-stage hardware startup launched in 2020 by Tesla alumni that is bringing the $26B recreational vehicle industry into the electric age. Based in San Francisco and Broomfield, Colorado, Lightship is designing and producing an aerodynamic, battery-powered trailer that liberates travelers from the noise, emissions, and range anxiety of gas RVing.