Associate Director – Study Site Engagement
| Company | Takeda |
|---|---|
| Location | Massachusetts, USA |
| Salary | $153600 – $241340 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, MD |
| Experience Level | Expert or higher |
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
- Flexibility
- Decision making
- Knowledge of clinical trials processes
- Knowledge of clinical trials regulations as per regional/country requirements
- Advanced knowledge and understanding of ICH-GCP
- Healthcare industry knowledge preferred
- Outsourcing/CRO knowledgebase
- Common computer programs and databases (such as MS Office)
Responsibilities
- Contributing to an effective partnership between Takeda study teams, study sites, and the Clinical Research Organization (CRO).
- Establishing communication with regional/country Medical Affairs (MA) and providing updates on study/site status.
- Supporting study teams with trial operations from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas.
- Enhancing engagement and offering added value by providing guidance and sharing knowledge with study sites.
- Supporting country and site identification, feasibility, site selection, study recruitment strategies, and mitigating barriers at the direction of Clinical Programs.
- Acting as an SSE-Program Lead (SSE-PL) and/or SSE-Study Lead (SSE-SL) as needed.
- Tracking feasibility progress and escalations for SSE/LOC support.
- Liaising with SSE-PL/SSE-SL, MA, local Clinical Operations team, and CRO staff for site identification and feasibility support.
- Tracking start-up hurdles escalated to the team and their resolution to ensure Site Initiation Visits (SIVs) and site activations are achieved as planned.
- Supporting recruitment strategy and activities when targets are not met.
- Regularly interacting with priority sites in assigned trials.
- Developing and maintaining long-term strategic relationships with selected sites/site networks.
Preferred Qualifications
- Healthcare industry knowledge preferred