Associate Clinical Project Management Director, Cross TA

IQVIA; Durham (NC); Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Remote work opportunity

Travel flexibility

Job summary

A global clinical research organization is seeking an experienced Associate Clinical Project Management Director to lead trial management activities. This role involves overseeing the Study Management Team, ensuring compliance and quality in trial execution. Candidates should have a Bachelor's degree in Life Sciences, a minimum of 8 years of experience, and strong leadership skills. The position offers a remote home-based opportunity with some travel required.

Qualifications

• Minimum 8 years of experience with proven leadership in complex trials.
• Strong knowledge of ICH-GCP and local regulatory requirements.
• Ability to manage ambiguity and drive solutions proactively.

Responsibilities

• Lead the Study Management Team and provide regular updates.
• Support site selection and feasibility assessments.
• Create and maintain trial-specific documents.
• Develop and deliver trial-specific training materials.

Skills

Leadership in complex trials

Knowledge of ICH-GCP

Communication skills

Analytical skills

Proficiency in Microsoft Office

Cross-functional team management

Education

Bachelor’s degree in Life Sciences

Tools

CTMS

TMF

Job description

Associate Clinical Project Management Director, Cross TA

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; escape 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 versus forecast; understand Out‑of‑Pocket (OOP) and FTE cost drivers.
• Remote & Travel – This is a remote home‑based role that may require some travel.

Qualifications

• Education – Bachelor’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent.
• Experience – 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.

Performance Metrics & KPIs

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Learn more at https://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. https://jobs.iqvia.com/eoe.