About the role
AI summarisedThe Associate Director, Study Site Engagement serves as the local face of Takeda, fostering effective partnerships between Takeda study teams, study sites, and the Clinical Research Organization (CRO). This role supports trial operations from Feasibility through CSR within assigned regions, enhancing engagement by providing guidance and nurturing long-term relationships with investigators and site personnel.
BiopharmaOnsiteClinical Development
Key Responsibilities
- Support the SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) in developing study site lists for feasibility, selection, and tracking progress.
- Liaise with SSE-PL/SSE-SL, Medical Affairs (MA), local Clinical Operations team, and CRO staff for site identification and feasibility support.
- Attend Pre-Study Visits (PSV) as requested or agreed upon with the SSE-SL.
- Support tracking of start-up hurdles escalated to the team and ensuring resolution for Site Initiation Visits (SIVs) and site activations.
- Support recruitment strategy and activities when targets are not met, including utilizing PR&R materials and conducting booster visits.
- Interact closely with the local CRO team throughout the study lifecycle.
- Attend Investigator Meetings in the region as invited and liaise with sites/CROs.
- Comply with internal guidelines and utilize company-provided tools for applicable tasks and reporting.
Requirements
- Ability to work independently and in teams.
- Proven ability to work cross-functionally globally.
- Strong global and cross-boundary communication skills.
- Demonstrated Business Acumen, Organization, Planning, and Time Management abilities.
- High level of Emotional Intelligence, Problem Solving, and Decision Making skills.
- Excellent Relationship Management & Influencing skills.
- Fluent in spoken and written English and Chinese (simplified).
- Flexibility to travel frequently in the assigned region (up to 40% during busy periods).