About the role
AI summarisedThe Associate Director, Study Site Engagement serves as Takeda's local representative, fostering partnerships between study teams, clinical sites, and CROs. This role supports trial operations from feasibility through study completion, drives site engagement strategies, manages relationships with investigators and site personnel, and may include people management responsibilities for senior staff. Frequent regional travel and cross-functional collaboration with Medical Affairs and Clinical Operations are required.
BiopharmaOnsiteClinical Development
Key Responsibilities
- Support SSE Program Lead/SSE Study Lead with development of study site list for feasibility and site selection
- Track feasibility progress and escalations for SSE/LOC support
- Report discrepancies on feasibility progress to SSE-PL/SSE-SL
- Liaise with SSE-PL/SSE-SL, MA, local Clinical Operations team, and CRO staff for site identification and feasibility support
- Attend Pre-Study Visit as requested or agreed upon with SSE-SL
- Follow up with country MA and local Clinical Operations team; track country and site selection activities
- Support tracking of start-up hurdles escalated to the team and their resolution to ensure SIVs and site activations are achieved
- Attend and/or support Site Initiation Visits
- Help track resolution of follow-up items post SIV until resolved by site or CRO/Takeda study team
- Attend Investigator Meetings in the region as invited; liaise with sites and CRO
- Support recruitment strategy and activities when targets are not met (e.g., utilization of PR&R materials, booster visits, phone contacts)
- Interact closely with local CRO team throughout the study lifecycle
Requirements
- Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science