Remote Clinical Data Abstractor Jobs in Raleigh, NC

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 athttps://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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. 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. We appreciate your honesty and professionalism.