Key Responsibilities

• Independently lead Medical Affairs + Health Impact (MHI) funded research, including Externally Sponsored Collabs & Non-Interventional Studies (NIS) (single & multi-country) from inception to closure, in compliance with quality standards.
• Support strategic leadership of the Cross-Functional Team.
• Drive deliverables & timelines. Lead & manage meetings with stakeholders.
• Manage vendors, recruitment, CTMS & eTMF.
• Maintain Inspection Readiness.
• Identify, mitigate & manage risks.
• Develop & manage study materials.
• Provide training to stakeholders.
• Support EDC, IRT, & ePRO design specifications, user acceptance testing, plans & key risk indicators, & system management activities.
• Manage IP & study supplies. Support process improvement initiatives & serve as a subject matter expert &/or mentor.