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Clinical Trials Project Manager

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Actalent

7d ago

  • Job
    Full-time
    Senior Level
  • Deerfield

AI generated summary

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

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 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 considering risks, budget, effort estimates, and schedule.

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

Applicants must have a BS Degree in Life Sciences or a related field, a minimum of 5 years of experience in Clinical Project Management or Clinical Trial Management from a CRO, and must have CRO experience.

Is experience in bid defense preparations necessary for this role?

Yes, the role requires participation in bid defense preparations and leading bid defense presentations in partnership with the business development team.

What is the importance of risk mitigation plans in this position?

Risk mitigation plans are crucial for proactively identifying potential risks and establishing appropriate communication and escalation strategies to minimize their impact on project objectives.

Will I be the point of contact for the Sponsor and other team members?

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

What knowledge is required regarding clinical trials?

Candidates should have knowledge of clinical trials, applicable regulatory requirements (GCP and ICH guidelines), RWE usage in clinical trials, and experience with EDC systems and technology-enabled solutions.

What financial management responsibilities does this position entail?

The Clinical Trials Project Manager is responsible for managing project finances in accordance with customer contracts and budgets, and closely working with the Director of Finance, RWE Clinical Trials.

How does Actalent incorporate diversity, equity, and inclusion into its culture?

Actalent incorporates DE&I through hiring diverse talent, maintaining an inclusive environment, building a culture of care and recognition, and ensuring growth opportunities for all employees.

Can candidates with disabilities request accommodations during the application process?

Yes, candidates can request reasonable accommodations for the job application or interviewing process due to a disability by emailing actalentaccommodation@actalentservices.com for alternative options.

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.