Associate Clinical Project Management Director, Cross TA at IQVIA

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent
Minimum 8 years of experience (Level 2 Advanced), 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

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

Key technologies and capabilities for this role

Clinical Trial ManagementStudy Management Team LeadershipTrial OversightVendor ManagementSite SelectionFeasibility AssessmentsEnrollment MonitoringBudget ManagementRegulatory ComplianceCAPA ProcessesInspection ReadinessInvestigator MeetingsTrial Documentation

Questions & Answers

Common questions about this position

What education is required for this role?

A Bachelor’s degree in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or equivalent is required.

What experience level is needed for the Associate Clinical Project Management Director position?

Minimum 8 years of experience is required at Level 2 (Advanced), with proven leadership in complex trials at a large pharmaceutical company.

What key skills are required for this Trial Delivery Manager role?

Required skills include 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, and proficiency in Microsoft Office, CTMS, TMF, and other clinical systems.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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