Evidence Generation Operations (Sr Manager/Associate Director) - Contract

ITF Therapeutics•Concord, MA

21d•$95 - $115•Remote

About The Position

We're looking for an Evidence Generation Operations Sr. Manager/Associate Director (Contract Position) 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. This role will be 40 hours/week and remote.

Requirements

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

Nice To Haves

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

Responsibilities

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