Associate Clinical Project Management Director, Cross TA

Key Responsibilities

• Trial Oversight & Management
• 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.
• Escalate and resolve trial issues and contribute to CAPA processes.
• Site & Vendor Coordination
• Support site selection and feasibility assessments.
• Monitor enrollment commitments and ensure recruitment plans are in place.
• Oversee selected vendors and review related deliverables and invoices.
• Capture and coordinate with vendors such as IVRS, Central Labs, ePRO, Imaging, Translation, and Ancillary Supplies.
• Documentation & Compliance
• Create and maintain trial-specific documents (e.g., Monitoring Guidelines, ICFs, Blinding Plans).
• Ensure timely filing, archiving, and retention of trial documents.
• Provide central documents for regulatory submissions.
• Support Health Authority inspections and internal audits.
• Training & Meetings
• Develop and deliver trial-specific training materials.
• Coordinate and participate in Investigator Meetings.
• Budget & Financial Oversight
• Establish country budgets and monitor actuals vs. forecast.
• Understand Out-of-Pocket (OOP) and FTE cost drivers.

Qualifications

• Education:
• Bachelor’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent.
• Experience:
• Level 2 (Advanced): Minimum 8 years of experience, with proven leadership in complex trials at a large pharmaceutical company.
• Skills & Competencies:
• Strong knowledge of ICH-GCP and local regulatory requirements.
• Proven ability to lead cross-functional teams and manage global trials.
• Excellent communication, decision-making, and analytical skills.
• Proficiency in Microsoft Office, CTMS, TMF, and other clinical systems.
• Experience in virtual team coordination and stakeholder engagement.
• Ability to manage ambiguity and drive solutions proactively.
• Preferred Attributes:
• Moderate to high-level monitoring or data management experience.
• Experience in budget planning and financial oversight.
• Ability to mentor junior CTMs and lead special initiatives or task forces.
• Therapeutic area expertise and ability to act as protocol expert.