Senior Clinical Project Manager

Meet Life Sciences; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

Meet Life Sciences is seeking a Senior Clinical Project Manager for a remote position in the US. This integral role will lead the planning, execution, and completion of clinical trials, ensuring adherence to regulatory standards and corporate objectives. The ideal candidate will have extensive experience in clinical research, particularly in managing oncology trials, and will facilitate collaboration across diverse teams to successfully deliver clinical studies.

Qualifications

• 10-12 years of clinical research experience, including 3 years as Clinical Trial Manager.
• Strong understanding of clinical trial processes and regulatory standards.
• Ability to travel up to 20%.

Responsibilities

• Manage clinical trials from initiation to closure, ensuring timelines and quality.
• Collaborate with cross-functional teams and manage vendor relations.
• Oversee trial-related documentation and compliance with GCP.

Skills

Knowledge of ICH GCP

FDA regulations

Clinical operations

Education

Bachelor’s degree in life/physical sciences or nursing

Tools

Clinical trial management systems

Medidata RAVE

Job description

Direct message the job poster from Meet Life Sciences

Senior Clinical Project Manager - Remote, US

Position Summary

This will oversee the planning, execution, and completion of assigned clinical trials, ensuring alignment with corporate objectives, regulatory standards, and timelines. This role involves close collaboration with cross-functional teams, vendors, and clinical sites to drive the successful delivery of clinical studies.

Key Responsibilities

• Project Oversight: Manage all aspects of clinical trials from initiation to closure, ensuring adherence to timelines, budgets, and quality standards.
• Cross-Functional Collaboration: Work closely with departments such as pre-clinical, manufacturing, data management, safety surveillance, biostatistics, and quality assurance to ensure cohesive trial execution.
• Vendor and Site Management: Serve as the primary liaison for vendors and clinical sites, addressing trial-related queries and issues.
• Documentation and Compliance: Oversee the development and maintenance of trial-related documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study plans, ensuring compliance with GCP and regulatory requirements.
• Monitoring and Reporting: Implement and adhere to monitoring plans, review monitoring reports, and track project milestones, providing regular status updates to stakeholders.
• Risk Management: Identify potential obstacles, develop mitigation strategies, and implement corrective and preventive action (CAPA) plans as necessary.
• Budget and Contract Negotiation: Negotiate site budgets and contracts, and manage study budgets effectively.
• Training and Development: Conduct team meetings, assign action items, and provide training as needed to ensure team alignment and performance.

Requirements:

• Bachelor’s degree in life/physical sciences or nursing.
• 10–12 years of clinical research experience, with at least 3 years as a Clinical Trial Manager or Clinical Project Manager.
• Strong knowledge of ICH GCP, FDA regulations, and clinical operations.
• Proficiency in clinical trial management systems and platforms such as Medidata RAVE.
• Ability to travel up to 20%.
• Prior involvement in oncology trials across Phases 1–3.

Please reach out to [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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