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Clinical/Development - Senior Manager, Medical Research
675 Kendall St Cambridge, MA 02147 US
Job Description
You will serve as a central point of contact for investigators, internal teams, and vendors, ensuring high-quality execution and oversight of the externally sponsored research. This role is ideal for a detail-oriented, relationship-driven scientific operations professional who thrives in a fast-moving, global environment.
Key responsibilities:
Serve as the primary point of contact for IIS and RC activities across regions
Manage communications and relationships with investigators, academic partners, and internal stakeholders
Oversee the full lifecycle of externally sponsored research, including concept intake, review, budget approval, contracting, study execution, and close?out
Coordinate Medical Affairs Review Board (MARB) meetings, including agenda development, document preparation, and minutes management
Track IIS/RC metrics and provide regular updates to Medical Affairs leadership
Ensure inspection readiness through complete, accurate, and readily retrievable documentation
Partner with GPSRM and QA to support audits and inspections
Provide oversight and collaborate with IIS portal vendor on issues and updates
Accountable for ensuring drug shipment activities comply with local/regional requirements and quality standards
Management of IIS and RC budgets, including annual budget planning
Proactively identify operational challenges and propose practical solutions
Contribute to initiatives aimed at improving investigator experience and internal efficiencies
Uphold and model clients in every aspect of work
Qualifications
BA/BS in Life Sciences or related field is required
Advanced degree or certification preferred
Proven experience in the pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies
Experience managing externally sponsored research (IIS/RC) strongly preferred
Strong working knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Excellent verbal and written communication skills
Strong relationship-building and stakeholder management capabilities
Highly organized, detail-oriented, and able to work independently
Solution-oriented mindset with strong problem-solving skills
Committed to high quality, integrity and alignment with Core Values
Pay ranges bwteen 45-52/hr based on expereince
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.
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