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Medical Affairs Operation Manager

9992
locationCambridge, MA, USA
PublishedPublished: 6/14/2022
Healthcare
Full Time

Job Description

Job Description

Period: 03/03/2026 to 09/04/2026

Job Title: Clinical/Development - Senior Manager, Medical Research

Location: Cambridge, MA 2147

Additional Information:
The Senior Manager, Medical Research - IIS & Research Collaborations plays a key role in advancing externally sponsored research initiatives. In this position, you will lead the operational execution and oversight of Investigator Initiated Studies (IIS) and Research Collaborations (RC), working closely with cross-functional teams to ensure efficient study execution.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‐outCoordinate 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 Alnylam quality standards Management of IIS and RC budgets, including annual budget planning Proactively identify operational challenges and propose practical solutionsContribute to initiatives aimed at improving investigator experience and internal efficiencies Uphold and model Alnylam Core Values 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

Company DescriptionIT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel.

Company Description

IT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel.

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