Remote Late Phase Research Project Manager, Medical Affairs Operations

Job Description

We are seeking a highly experienced, organized, and motivated Clinical Study Manager (CSM) to join our dynamic Global Medical Affairs Operations team. This pivotal role will oversee late-phase, non-interventional studies and support the execution of medical affairs-driven research initiatives. Reporting to the Associate Director, Medical Program Management, the CSM will collaborate with Medical Strategy leadership, ensuring operational excellence in study management while contributing to broader medical affairs projects.

The ideal candidate will possess extensive expertise in late-phase study management and operational oversight, with a strong background in program/project management and cross-functional collaboration within the biotechnology or pharmaceutical industry.

Duties Include, But Are Not Limited To

• Provide day-to-day operational oversight and management for late-phase, non-interventional studies, ensuring compliance with regulatory, ethical, and organizational standards.
• Collaborate with cross-functional teams (medical, regulatory, legal, and compliance) to drive study progress, manage deliverables, and resolve operational challenges.
• Develop and manage study timelines, budgets, and resource allocation, ensuring alignment with organizational goals.
• Support protocol development, vendor selection and oversight, and study-specific operational plans.
• Monitor study progress, generate status reports, and communicate key updates to stakeholders, ensuring proactive resolution of potential roadblocks.
• Oversee the collection, review, and submission of study documents to ensure audit readiness and compliance with SOPs and regulatory requirements.
• Partner with Medical Strategy leadership to identify and address strategic priorities in late-phase research, contributing to broader medical affairs initiatives.
• Assist in the development and implementation of medical affairs processes, global planning templates, and operational best practices.
• Support operational and project management activities for other key medical affairs initiatives, including advisory boards, medical education programs, and engagement activities.
  
  

Requirements

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or related field (advanced degree preferred).
• 5 years in clinical study management, with a focus on late-phase and non-interventional studies within biotechnology or pharmaceutical industries. Additional project management experience preferred.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.