Clinical Study Manager

Role: Manager, Medical Research – IIS & Research Collaborations

Location / Work Arrangement: Cambridge, MA (Hybrid) or Virtual (East Coast only; CST/PST not eligible)

Duration: 6-month contract

Target Start Date: Early March – no later than April 1

Work Hours: Standard EST business hours; no weekend work

Pays: Between $53 to $56 an hour or about $115,000 a year

Position Overview

The Manager, Medical Research – IIS & Research Collaborations is responsible for leading the operational execution and oversight of Investigator Initiated Studies (IIS) and Research Collaborations (RC), including externally sponsored research. This role serves as the central point of contact for investigators, internal teams, and vendors, ensuring efficient study execution, compliance, and high-quality outcomes. The ideal candidate is a detail-oriented, relationship-driven scientific operations professional who thrives in a fast-paced, global environment.

This role will focus on Phase 4 clinical trials for commercial products and requires strong senior project management experience in clinical trials/research studies. Standard EST business hours, no weekend work.

Tools: Ariba (POs, invoices, agreements), SharePoint, and other legal/contracting tools.

Key Responsibilities

• Serve as the primary point of contact for IIS and RC activities across regions.
• Manage communications and maintain strong relationships with investigators, academic partners, internal stakeholders, and vendors.
• Oversee the full lifecycle of externally sponsored research: 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 with complete, accurate, and easily retrievable documentation.
• Partner with GPSRM and QA teams to support audits and inspections.
• Collaborate with IIS portal vendors on issues and updates.
• Ensure drug shipment activities comply with local/regional requirements and Alnylam quality standards.
• Manage IIS and RC budgets, including annual planning.
• Identify operational challenges proactively and propose practical solutions.
• Contribute to initiatives that improve investigator experience and internal efficiency.
• Uphold and model Alnylam Core Values in all aspects of work.

Candidate Requirements

Education:

• BA/BS in Life Sciences or a related field required.
• MS, PhD, or relevant certification preferred.

Experience:

• Minimum 3–5+ years in senior project management within clinical trials or research studies.
• Proven experience managing Investigator Initiated Studies (IIS) and research collaborations, including externally sponsored research.
• Experience with Phase 4 clinical trials and commercial products.
• Knowledge of GCP/GPP, ICH guidelines, and clinical research processes.

Skills:

• Excellent verbal and written communication.
• Strong stakeholder management and relationship-building abilities.
• Highly organized, detail-oriented, and able to work independently.
• Solution-oriented with strong problem-solving capabilities.
• Ability to track multiple projects across various phases simultaneously.