Associate Director Study Site Engagement

Takeda; Remote; SGD 120,000 - 160,000; Full time

Job summary

A global pharmaceutical company based in Singapore is seeking an experienced Associate Director for Study Site Engagement to foster partnerships with clinical research sites and enhance engagement strategies. The ideal candidate should have over 10 years of clinical research experience, possessing strong leadership, communication skills, and the ability to work cross-functionally. You will support study operations and contributions across various therapeutic areas. This position offers a full-time contract inside a dynamic and collaborative environment.

Qualifications

• 10+ years of experience in clinical research, either with a CRO or a pharmaceutical company.
• Ability to work with study sites and CROs effectively.
• Proven track record in managing study engagement initiatives.

Responsibilities

• Contributes to effective partnerships between Takeda study teams and study sites.
• Supports trial operations from feasibility through CSR within assigned regions.
• Enhances engagement with study sites, providing guidance and knowledge.

Skills

Ability to work independently and in teams

Work cross-functionally 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

Fluent in Chinese (simplified)

Knowledge of Traditional Chinese

Education

Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare

Job description

Objectives/Purpose

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).

• Establishes communication with regional/country Medical Affairs (MA), provides updates on study/site status, and establishes site engagement study-specific strategies.
• Supports study teams with trial operations from feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
• 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 site personnel. Supports country and site identification, feasibility, site selection, study recruitment strategies, and mitigates barriers at the direction of Clinical Programs.
• May act as an SSE-Program Lead (SSE-PL) and/or SSE-Study Lead (SSE-SL).

Accountabilities

• 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 a study site list for feasibility, site selection, and tracking feasibility progress and escalations for SSE/LOC support.
• Reports discrepancies on feasibility progress to SSE-PL/SSE-SL
• Liaises with SSE-PL/SSE-SL, MA, local Clinical Operations (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 follow up with country MA, local Clinical Operations team and track 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 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 ongoing global clinical studies, focusing on country landscaping, upcoming feasibilities, study status and enrollment updates, specific site issues and HCPs contacted in the region/country.

• SSE Program Lead and/or SSE Study Lead for assigned programs – Plays a key role in shaping the global Site Engagement Strategy for the assigned trial, adapting it to meet country requirements. Attends program and study level meetings and provides updates to SSE team members. Attends kick-off meetings, investigator meetings (in region).

• Development of Strategic Site Relationships – May be responsible for developing and maintaining long-term strategic relationships with selected sites/site networks.

• Conferences, Congresses, Other Site Facing Events – May be tasked with developing and executing the SSE strategy for non-study specific activities within the designated Therapeutic Area (TA) or Country. Participation in conferences or congresses to engage with sites beyond their locations.

Education, Behavioural Competencies And Skills

Education

• Scientific degree (MD, PhD, MA/MS, BA/BS) in pharmaceutical science, chemistry, biology, medical/healthcare is preferred but not mandatory.

Experience

• 10+ years of experience in clinical research, either with a CRO or a pharmaceutical company, focusing on clinical trials. Total cumulative work experience may be considered.

Essential Qualifications

• Ability to work independently and in teams
• Work cross-functionally 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

Locations

• SGP - Singapore Remote

Worker Type

• Employee

Worker Sub-Type

• Regular

Time Type

• Full time