Services Overview: 

·  Global/Regional Clinical Trial Leadership: Lead the Study Management Team (SMT) and oversee end-to-end clinical trial delivery, including feasibility, site selection, study start-up, trial execution, database lock, and close-out activities. Serve as a key partner to the Trial Delivery Leader (TDL).

·  Cross-functional Stakeholder & Vendor Management: Collaborate with CROs, country teams, and global vendors (e.g., Central Lab, IWRS/IVRS, ePRO), while partnering with Study Responsible Physicians, Data Managers, Supply Managers, and other stakeholders to drive issue resolution and escalation management.

·  Project Leadership & Quality Oversight: Accountable for study timelines, enrollment, budgets, documentation, inspection readiness, CAPA management, and GCP compliance. Advanced-level TDMs may lead complex global programs and provide coaching and mentorship to other TDMs.

Deliverables: 

• Autonomy in execution of clinical trial management services. 

• Depth of knowledge with clinical trial management services. 

• Provide coaching/mentoring to less experienced TDMs, if applicable. 

• Assumes additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert, as applicable. 

• Given assignments that are more complex and/or have a greater potential impact on business results.  

• Lead a team of TDMs across a project/program, on insourced and outsourced studies. 

Education and Experience Requirements:  

• 8 years clinical trial management experience in the pharmaceutical industry or CRO. Require 3-4 years of global project management experience.  Specific therapeutic area experience. 

• Ability to proactively and autonomously identify and preempt budget issues and work with key stakeholders to resolve. 

• Strong leadership, project management, stakeholder management, budgeting, and English communication skills are essential.