Associate Clinical Project Management Director, Cross TA

5PY IQVIA RDS Inc.; Lake Hiawatha (NJ); Remote; USD 100,000 - 130,000; Full time

Job summary

A clinical research organization is seeking an experienced Associate Clinical Project Management Director to lead global clinical trial management. The ideal candidate has over 8 years of experience in pharmaceutical trials, strong leadership skills, and proficiency in regulatory compliance. This position is remote with potential travel and requires a bachelor's in Life Sciences. A supportive work environment is offered, with a commitment to equal opportunity employment.

Qualifications

• Minimum 8 years of experience with proven leadership.
• Strong understanding of regulatory requirements.
• Experience in budget planning and financial oversight.

Responsibilities

• Lead the Study Management Team and provide updates.
• Ensure tracking and documentation of trial progress.
• Develop and deliver trial-specific training materials.
• Establish country budgets and monitor actuals.

Skills

Leadership in complex trials

Strong knowledge of ICH-GCP

Excellent communication skills

Proficient in Microsoft Office

Analytical skills

Virtual team coordination

Education

Bachelor’s degree in Life Sciences or equivalent

Tools

CTMS

TMF

Job description

Overview

Position Overview: 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. The TDM will serve as a key member of the Study Management Team (SMT), supporting trial leaders and interfacing with internal and external stakeholders to ensure compliance, quality, and timely delivery of trial milestones.

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.
• 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:

• 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.

This is a remote home-based role that may require some travel.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. Learn more at jobs.iqvia.com/eoe