Search Jobs
Remote Late Phase Research Project Manager, Medical Affairs Operations
45 Sidney Street, 001 Cambridge, MA 02139 US
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.
- 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Cambridge, MA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.