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 manage vendor interactions 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 advanced 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.

Metrics & KPIs

• Performance will be measured according to the Quality Oversight Plan (QOP) and trial-specific deliverables.

Location

• Home-based

Culture

• IQVIA is committed to integrity in its hiring process and maintains a zero tolerance policy for candidate fraud. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.