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Clinical Trials Project Manager

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Actalent

3mo ago

  • Job
    Full-time
    Senior Level
  • Research & Development
  • Deerfield

AI generated summary

  • You must have CRO clinical trial experience, a BS in Life Sciences, 5+ years in project management, knowledge of RWE, EDC systems, GCP/ICH guidelines, and project finance management.
  • You will lead project activities, manage budgets, serve as the main contact for stakeholders, establish documentation, develop risk mitigation plans, and ensure compliance while identifying process improvements.

Requirements

  • MUST have CRO Clinical Trial experience
  • BS Degree in Life Sciences or related field
  • MUST have CRO experience
  • Must have a minimum of 5 years of experience as a Clinical Project Management or Clinical Trial Management from a CRO
  • Knowledge of the use of RWE for clinical trials
  • Knowledge of EDC systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in clinical trials
  • Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (GCP and ICH guidelines)
  • Knowledge of project finances including experience managing, contractual obligations and implications

Responsibilities

  • Lead and coordinate project activities and leads completion of deliverables in alignment with overall program strategy considering impact to risks/risk mitigation, budget, effort estimates and schedule
  • Serve as the point of contact for the Sponsor and other functional team members for the assigned clinical trial project
  • Participate in bid defense preparations; Lead bid defense presentations in partnership with the business development team
  • Lead activities across numerous functions to meet the objectives of a given program including scope, budget, and schedule
  • Establish and maintain project documentation and procedures
  • Develop risk mitigation plans including appropriate communication and escalation plans to mitigate risk
  • Collaborates closely with other core team leaders within the Clinical Trials business
  • Demonstrates the ability to proactively identify solutions to improve existing business processes
  • Understands and maintains compliance with internal and external privacy and legal
  • Manage the project finances in accordance with the customer contract and the budget; work closely with the Director of Finance, RWE Clinical Trials
  • Identify changes in scope and manage the change control process, as necessary

FAQs

What qualifications are required for the Clinical Trials Project Manager position?

A BS Degree in Life Sciences or a related field is required, along with a minimum of 5 years of experience in Clinical Project Management or Clinical Trial Management from a CRO.

Is CRO experience mandatory for this role?

Yes, having CRO Clinical Trial experience is a must for this position.

What is the primary responsibility of the Clinical Trials Project Manager?

The primary responsibility is to lead and coordinate project activities, ensuring the completion of deliverables in alignment with the overall program strategy, while managing risks, budgets, and schedules.

Can you explain the role of the Clinical Trials Project Manager in financial management?

The Clinical Trials Project Manager is responsible for managing project finances in accordance with the customer contract and budget, collaborating closely with the Director of Finance.

What kind of project documentation is expected to be maintained?

The project manager is expected to establish and maintain comprehensive project documentation and procedures throughout the lifecycle of the clinical trial project.

Will I need to engage with Sponsors and other team members?

Yes, the Clinical Trials Project Manager will serve as the main point of contact for the Sponsor and other functional team members for the assigned clinical trial project.

What experience is necessary regarding compliance with regulatory requirements?

Candidates should have experience applying applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

Is knowledge of electronic data capture (EDC) systems required for this role?

Yes, knowledge of EDC systems and technology-enabled solutions, including EMR/Health Record experience and hybrid trials, is necessary.

How does the company approach diversity and inclusion?

Actalent actively promotes diversity and inclusion through hiring diverse talent, maintaining an inclusive environment, providing growth opportunities, and fostering a culture of care and engagement.

What should I do if I need a reasonable accommodation during the application process?

If you require a reasonable accommodation due to a disability, you can email actalentaccommodation@actalentservices.com for assistance with the job application or interviewing process.

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Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.