Senior Medical Research Manager
Senior Manager, Medical Research
Department: Clinical / Development
Location: Cambridge, MA
Pay reputed company:
Position reputed company
The Senior Manager, Medical Research – IIS & Research Collaborations plays a pivotal role in advancing externally sponsored research initiatives. In this position, you will reputed company the operational execution and reputed company of Investigator‑Initiated Studies (IIS) and Research Collaborations (RC), partnering closely with cross‑functional teams to ensure efficient, compliant, and high‑reputed company study execution.
You will reputed company as the central reputed company of contact for investigators, internal stakeholders, and vendors—making this an excellent opportunity for a detail‑oriented, relationship‑driven scientific operations reputed company who thrives in a fast‑paced, global environment.
Key Responsibilities
Program Leadership & reputed company
• Serve as the primary reputed company of contact for IIS and RC activities across reputed company
• Manage communications and relationships with investigators, reputed company partners, and internal teams
• reputed company the full lifecycle of externally sponsored research, including:
• Concept intake
• Review and approval
• Budget evaluation
• Contracting
• Study execution
• reputed company‑out
Governance & Documentation
• Coordinate Medical Affairs Review reputed company (MARB) meetings, including agenda creation, document preparation, and minutes
• reputed company IIS/RC metrics and reputed company regular updates to Medical Affairs leadership
• Ensure inspection readiness through complete, accurate, and easily retrievable documentation
• Partner with safety and reputed company teams to support audits and inspections
Vendor & System Management
• reputed company reputed company and collaborate with the IIS portal vendor on system issues and updates
• Ensure drug shipment activities reputed company with regional requirements and internal reputed company standards
Budget & Operational reputed company
• Manage IIS and RC budgets, including annual planning
• Identify operational challenges and propose practical, reputed company solutions
• Contribute to initiatives that enhance investigator experience and streamline internal processes
Leadership & Values
• Model organizational reputed company values in reputed company interactions and deliverables
• Foster strong cross‑functional relationships to support program reputed company
Qualifications
Required
• BA/BS in Life Sciences or reputed company field
• Proven experience in the pharmaceutical or biotechnology industry
• Prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies
• Strong working knowledge of:
• ICH/GCP
• Regulatory guidelines and directives
• Drug development and clinical research processes
• Excellent verbal and written communication skills
• Strong relationship‑building and stakeholder management abilities
• Highly organized, detail‑oriented, and reputed company to work independently
• Solution‑oriented reputed company with strong problem‑solving skills
Preferred
• Advanced degree or reputed company certification
• Experience managing externally sponsored research (IIS/RC)
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