Note: The job is a remote job and is open to candidates in USA. IQVIA is seeking an experienced Associate Clinical Project Management Director/Trial Delivery Manager (TDM) to lead and coordinate global and regional clinical trial management activities. This role ensures the successful planning, execution, and closure of clinical trials, whether internally managed or outsourced.
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
- Escalate and resolve trial issues and contribute to CAPA processes
- 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
- Coordinate with vendors such as IVRS, Central Labs, ePRO, Imaging, Translation, and Ancillary Supplies
- 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
- Develop and deliver trial-specific training materials
- Coordinate and participate in Investigator Meetings
- Establish country budgets and monitor actuals vs. forecast
- Understand Out-of-Pocket (OOP) and FTE cost drivers
Skills
- 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
- 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
- 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
Benefits
- Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Company Overview
Company H1B Sponsorship