Associate Director, Study Site Engagement

Overview

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Job Description

• The Associate Director, Study Site Engagement is the local face of Takeda by contributing to an effective partnership between Takeda study teams, study sites and the Clinical Research Organization (CRO) (i.e., the Clinical Research Associate (CRA)).
• The Associate Director, Study Site Engagement establishes communication with regional/country Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study specific strategies.
• Associate Director, Study Site Engagement supports study teams with trial operations from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
• The Associate Director, Study Site Engagement enhances engagement and offers added value by providing guidance and sharing knowledge with study sites, while establishing and nurturing long-term relationships with investigators and study site personnel. The Associate Director, Study Site Engagement supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
• The Associate Director, Study Site Engagement supports Takeda study teams as part of their day-to-day responsibilities and may act as an SSE-Program Lead (SSE-PL) and/or SSE-Study Lead (SSE-SL).

Study Specific Engagement activities:
Early engagement - Country and site feasibility

• 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.

Study startup phase - Post site selection to site initiation

• 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.
• As invited, attends Investigator Meetings (in the region) and liaises with sites / CRO.

Enrollment and study conduct phase

• 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.

Training

• Applicable local regulations
• SOP trainings (Takeda and CRO, as applicable)
• TA/Study specific training

The Associate Director, SSE is expected to comply with internal guidelines and utilize company-provided tools (i.e., MS Forms, etc.), for applicable tasks and reporting.

• Non-Study Specific Engagement activities
• Participation in following activities may vary depending on assignment by Line Manager

People Management:

• The Associate Director, Study Site Engagement, may be responsible for resource and talent management of Sr. Managers and/or Managers, SSE (as applicable) across relevant regional/country clusters to achieve site engagement deliverables and GDO objectives.

Cross-functional role:

• Establishes communication and regular interactions with regional/country Medical Affairs (MA) and provides updates on planned and…