Associate Project Manager – Externally Sponsored Research
Core
Operational oversight of unsolicited research support requests (Investigator-Sponsored Studies and Externally Sponsored Collaborations) to ensure compliant study review, start-up, execution, and tracking of milestones.
Role type
Associate Project Manager (Externally Sponsored Research)
Builds
Externally Sponsored Research (ESR) programs and study deliverables for Specialty Care, Vaccines, and R&D functions.
Domain
Pharmaceutical industry, Clinical Research, Regulatory Compliance
Deliverable
client delivery
Required skills
Clinical trial project management, study operational management, regulatory compliance (GCP, ICH), budget and payment tracking, system of record management, cross-functional collaboration, data analytics, process improvement
Preferred skills
Project management certification, knowledge of Medical Investigator Sponsored Studies program requirements, understanding of external regulations (OIG, PhRMA code), product supply forecasting
Technologies
iEnvision, SharePoint
Responsibilities
Manage overall study operational activities from proposal submission to closeout; Execute ESR process activities compliantly per SOPs; Collaborate cross-functionally for efficient delivery of research agreements and product supply; Support development of metrics and KPIs to measure progress; Oversee ESR system of record and maintain data integrity; Coordinate with R&D and Product Supply teams for demand forecasting; Disseminate safety updates and Dear Investigator Letters; Manage team training and access to ESR tools; Perform initial Quality Check of ESR submissions; Manage workflow in iEnvision; Oversee ESR budget and payment/invoice tracking; Coordinate for ESR audits.
Seniority
Mid-level, hands-on IC
