Evidence Generation Operations; Sr Manager​/Associate Director

Sr. Manager/AD, Evidence Generation Project Manager – Contract Position

3 days ago – Be among the first 25 applicants

Reports To:

Medical Lead, Evidence Generation, Italfarmaco

We're looking for an Sr. Manager/Associate Director, Evidence Generation Project Manager (Contract Position) who drives the execution of post‑marketing observational studies, ensuring operational excellence across study start‑up, site engagement, documentation, and cross‑functional alignment. Reporting to the Head of Evidence Generation, you’ll oversee CRO performance, manage project timelines and financials, and uphold quality standards to support robust real‑world evidence generation.

• Lead the operational excellence of post‑marketing observational studies for commercial product(s). This includes:
  • Supporting the oversight of study CRO(s)
  • Leads site start‑up and site engagement in partnership with CRO
  • Coordinates review and finalization of study documents
  • Develop, maintain, and optimize project trackers, timelines, and dashboards to ensure visibility and accountability
  • Manages all aspects of meeting management (scheduling, agenda, minutes)
  • Coordinates with cross‑functional team members (Clinical development, Biostats, Data management, Regulatory Affairs, Medical affairs & Patient Advocacy) to ensure operational strategy alignment
  • Proactively identifies project risks and resolves with some supervision
• Project management of all Evidence Generation activities, including:
  • Overseeing and managing all aspects of Evidence Generation project contracting and financials (budget, invoice accruals) in concert with finance and legal departments
  • Maintain Evidence Generation SharePoint to ensure documentation is up to date and accessible for effective cross‑functional communication
  • Leads the development of SOPs and Work Instructions as it pertains to observational research
  • Ensures project and quality management standards/processes are adhered to by cross‑functional project teams

You are an experienced observational research professional with a strong command of RWE methodologies and a proven ability to manage complex, multi‑stakeholder projects. You thrive in a fast‑paced, highly collaborative environment, bringing exceptional communication skills, organizational rigor, and a proactive approach to risk and quality management.

• A minimum of 5 years of relevant experience is required
• Experience with RWE/observational research is required
• Proficiency with MS Office, MS Teams, Share Point
• Excellent written and verbal communication skills, and ability to manage multiple tasks simultaneously
• Ability to travel approximately 25%, including international travel
• East‑coast based

• Experience working on rare diseases is preferred
• Experience conducting observational research in Europe is preferred
• Experience collaborating with disease registries is preferred

The base compensation range for this role is: $95-$115/hour. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Mid‑Senior level

Contract

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