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ITF Therapeutics LLC · 1 day ago

Sr. Manager/AD, Evidence Generation Project Manager - Contract Posititon

Concord, MA

Contract

Hybrid

Senior Level, Lead/Staff, Director/Executive

$95/hr - $115/hr

5+ years exp

ITF Therapeutics LLC is looking for a Sr. Manager/Associate Director, Evidence Generation Project Manager to drive the execution of post-marketing observational studies. The role involves overseeing CRO performance, managing project timelines and financials, and ensuring quality standards for robust real-world evidence generation.

ManufacturingPharmaceuticalTherapeutics

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