Associate Clinical Project Management Director, Cross TA

Responsibilities

• Lead the Study Management Team and provide regular updates on trial deliverables.
• Ensure real-time tracking and documentation of trial progress.
• Maintain inspection‑readiness throughout the trial lifecycle.
• Act as the primary contact for country and regional staff and internal teams.
• Partner with Global Trial Leads to oversee central trial activities from start‑up to close‑out.
• Create and maintain trial‑specific documents (e.g., Monitoring Guidelines, ICFs, Blinding Plans).
• Establish country budgets and monitor actuals vs. forecast.

Requirements

• Bachelor’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent.
• Minimum 8 years of experience, with proven leadership in complex trials at a large pharmaceutical company.
• Strong knowledge of ICH-GCP and local regulatory requirements.
• Proven ability to lead cross-functional teams and manage global trials.
• Proficiency in Microsoft Office, CTMS, TMF, and other clinical systems.
• Experience in virtual team coordination and stakeholder engagement.

Core Competencies

Demonstrates expertise in leading complex clinical trials, ensuring compliance with ICH-GCP and local regulatory requirements, while effectively managing cross-functional teams and maintaining trial documentation. Proficient in budget management and stakeholder engagement within the pharmaceutical industry.