About the role

AI summarised

The Associate Director, Study Site Engagement at Takeda serves as the local face of the company, fostering partnerships between study teams, sites, and CROs. This role involves overseeing site engagement strategies, supporting trial operations from feasibility through CSR, and developing long-term relationships with investigators. The position requires 10+ years of clinical research experience and fluency in English and Chinese.

BiopharmaFull-timeClinical Development

Key Responsibilities

Supports the SSE Program Lead (SSE-PL)/SSE Study Lead (SSE-SL) with the development of study site list for feasibility - site selection and aids in tracking feasibility progress and escalations for SSE/LOC support.
Reports any discrepancy on feasibility progress to SSE-PL/SSE-SL.
Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations team (if available) and CRO staff for site identification and feasibility support in alignment with global study team.
Attends Pre-Study Visit (PSV) as requested or agreed upon with the SSE-SL.
Helps to follow up with country MA, local Clinical Operations team and keep track of country and site selection activities.
Supports the SSE-PL/SSE-SL in tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
Attends and/or supports SIVs.
Helps SSE-PL/SSE-SL in tracking resolution of any follow-up item needed post SIV until resolved by site and or CRO/Takeda study team.
Supports recruitment strategy and activities when targets are not met (e.g. utilization of PR&R materials, booster visits, phone contacts).
Interacts closely with local CRO team throughout the lifecycle of the study.
Helps coordinate and/or attend booster visits or other activities requested by SSE-PL/SSE-SL.
Regularly interacts with priority sites in assigned trials.

Requirements

Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare is preferred but not mandatory.
10+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials.
Ability to work independently and in teams.
Work cross-functional globally.
Global and cross boundary communication.
Business Acumen.
Organization and planning.
Time management.
Emotional intelligence.
Problem solving.
Relationship Management & Influencing skills.
Fluent in spoken & written English and Chinese (simplified); knowledge of Traditional Chinese is an asset.
Flexibility.
Decision making.
Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 40% during busy period).