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We are currently seeking a detail-oriented Clinical Data Manager to join a well-known client’s team in Durham, NC. This role is responsible for managing clinical data collection, validation, and analysis to ensure high-quality, compliant datasets that support clinical research and development.
The Clinical Data Manager will play a critical role in overseeing clinical databases, ensuring data integrity, and collaborating with cross-functional teams and external vendors to deliver accurate and timely study data. This position offers the opportunity to contribute to clinical programs by applying strong data management expertise in a regulated environment.
RESPONSIBILITIES
• Manage and support clinical data activities, including data collection, review, validation, and analysis.
• Perform User Access Management within Veeva Vault EDC systems.
• Design and develop data review listings, custom reports, and specifications using Veeva Vault CDB.
• Conduct User Acceptance Testing (UAT) for EDC and CDB systems; document findings and collaborate with teams to resolve issues.
• Design and validate Case Report Forms (CRFs) and clinical databases, including development and testing of edit/logic checks.
• Develop and maintain Data Management Plans (DMPs), including workflows for coding, data transfer, and database lock activities.
• Generate and manage data queries to resolve discrepancies and ensure data completeness and accuracy.
• Design and implement Data Transfer Specifications (DTS) for external data integration.
• Perform quality control (QC) audits and monitor compliance with SOPs and regulatory standards.
• Oversee and review data management deliverables from CROs and external vendors.
• Support clinical trial data operations, including data entry, verification, and reconciliation activities.
• Collaborate with cross-functional teams to identify trends and report data insights.
EXPERIENCE
• Demonstrated experience in clinical data management within a regulated clinical research environment.
• Hands-on experience with Veeva Vault EDC and Veeva Vault CDB required.
• Strong knowledge of clinical database design, validation, and data review processes.
• Experience managing or overseeing CRO/vendor deliverables.
• Familiarity with clinical trial workflows, data standards, and regulatory requirements (e.g., GCP).
• Strong analytical skills with the ability to identify trends and resolve data issues.
EDUCATION
• Bachelor’s degree in Management Information Systems, Life Sciences, Computer Science, or a related field required.
• Equivalent combination of education and experience may be considered.
TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
• Strong technical expertise in EDC systems and clinical data management tools.
• Excellent attention to detail and commitment to data accuracy and integrity.
• Strong organizational and time management skills with the ability to manage multiple priorities.
• Effective communication and collaboration skills across cross-functional teams.
• Problem-solving mindset with the ability to identify and resolve data-related issues.
• Ability to work independently while maintaining alignment with team goals.
• Knowledge of clinical research regulations and quality standards.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].
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