Position: Senior Clinical Data Manager
Location: Durham, North Carolina (Home-Based)
Job ID: R1510472
Employment Type: Full-Time
Function: Integrated Data Analytics & Reporting
Available Locations: North Carolina and additional remote options
Job Overview
The Senior Clinical Data Manager (CDM) provides advanced clinical data management and scientific data review expertise, working closely with Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This role ensures data integrity, regulatory compliance, and high-quality deliverables throughout the lifecycle of clinical studies — from protocol design through database lock.
Key Responsibilities
Clinical Data Review & Scientific Oversight
Perform complex scientific clinical data reviews in collaboration with SRP and SRS.
Provide data management expertise across multiple moderate-complexity studies or one high-complexity trial.
Review all data flows and Data Management Plans (DMPs) to ensure accuracy, consistency, and compliance.
Conduct ongoing scientific data review activities, including medical coding and SAE reconciliation as applicable.
Manage clinical data queries in the electronic data capture (eDC) system and communicate effectively with SRP/SRS.
Study Design & Protocol Development
Contribute to protocol design and data collection tool development, ensuring alignment with therapeutic and clinical objectives.
Collaborate with SRP, SRS, and Data Management functions to define and refine study-specific data management strategies.
Develop and maintain the Integrated Review Plan (IRP) — ensuring scientific clarity, accuracy, and regulatory compliance.
Leadership & Collaboration
Act as the primary CDM point of contact for assigned trials, leading cross-functional discussions with SRP/SRS, CROs, and internal teams.
Partner with Global Data Managers (GDMs) to establish and confirm scientific review expectations.
Provide leadership and guidance to junior CDMs and data review teams.
Plan, track, and ensure timely delivery of CDM deliverables.
Lead or participate in team meetings, client discussions, and cross-functional review sessions.
Compliance & Quality Assurance
Ensure full adherence to Client SOPs, WIs, policies, ICH-GCP guidelines, and local regulatory requirements.
Maintain real-time inspection readiness of all deliverables and participate in regulatory audits as needed.
Guarantee all data management deliverables meet quality, documentation, and submission standards.
Qualifications
Education
Bachelor’s or higher degree (preferably in Health Sciences or a related field).
Alternatively, a Bachelor’s degree in another discipline with relevant clinical or data management experience.
Experience
Minimum 5 years of Data Management experience, including leadership or project oversight responsibilities.
Proven experience in clinical data review, preferably in the pharmaceutical or CRO industry.
Strong knowledge of medical terminology and clinical trial processes.
Demonstrated experience in collaboration with Clinical, Statistical, and Data Management teams.
Solid understanding of clinical drug development and regulatory documentation standards.
Compensation
Base Pay Range: USD $86,800 – $217,100 (annualized)
Actual pay depends on qualifications, experience, location, and employment type.
Additional compensation may include bonuses, incentive plans, and comprehensive health/welfare benefits.
About IQVIA
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights. We connect data, technology, and expertise to accelerate the development and commercialization of innovative medical treatments — improving patient outcomes and public health worldwide.
🔗 Learn more: https://jobs.iqvia.com
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