Clinical Data manager
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Medical, Dental, Vision, Retirement
Posted 2 days ago
Job description
Location: Durham, NC 27709
Duration: 9 Months
Job Summary:
The Clinical Data Manager will apply his or her knowledge of Clinical Research, therapeutic areas and Clinical database management to collect, review and analyze clinical data, and to identify and report trends.
Supervisory Responsibilities:
• Provide oversight and QC the CDM deliverables of tasks outsourced to CROs.
Duties/Responsibilities:
• Performs User Access Management in Veeva vault EDC, create specifications for data review listings, custom listings in Veeva vault CDB.
• Performs User acceptance testing in Veeva EDC and CDB, document findings in electronic logs and work with the study team members and vendors to resolve the issues.
• Designs and validates CRFs, clinical databases including designing or testing logic checks. Develops project-specific eCCG, data management plans that address areas such as data coding, reporting, or transfer, database locks, and work-flow processes.
• Generates data queries based on validation checks or errors and omissions identified during data review to resolve identified problems.
• Designs DTS for receiving, processing, or tracking data. Processes clinical data transfers including receipt, entry, verification, or filing of information.
• Performs quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data. Monitors work productivity or quality to ensure compliance with standard operating procedures.
• Performs other related duties as assigned.
Required Skills/Abilities:
• Excellent knowledge of computers and EDC systems, and administration and management skills.
• Veeva vault EDC, CDB experience.
Education and Experience:
• Bachelor's degree in management information systems or other computer-related, science-related fields required or equivalent experience.
Physical Requirements:
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 10 pounds at times.
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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Clinical Data Manager?
A: To succeed as a Clinical Data Manager, key technical skills include proficiency in Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC) systems, and data management software such as SAS or R. Additionally, strong domain-specific skills in clinical research regulations, Good Clinical Practice (GCP), and data validation are essential.\n\nSoft skills that contribute to success in this role include strong organizational and time management skills, effective communication and collaboration with cross-functional teams, and attention to detail and analytical thinking to ensure data accuracy and integrity. These strengths enable Clinical Data Managers to efficiently manage large datasets, identify and resolve data discrepancies, and maintain compliance with regulatory requirements.\n\nBy possessing these technical and soft skills, Clinical Data Managers can effectively oversee data collection, cleaning, and analysis, ultimately supporting the success of clinical trials and contributing to the growth of their careers in the pharmaceutical or biotechnology industry.
Q: What is the career path for a Clinical Data Manager?
A: A Clinical Data Manager's career path typically begins with entry-level roles such as Clinical Data Coordinator or Data Associate, where they assist in data management, cleaning, and reporting. As they gain experience, they progress to mid-level roles like Clinical Data Manager or Senior Data Coordinator, overseeing data management processes, implementing data standards, and collaborating with cross-functional teams. Senior Clinical Data Managers or Lead Data Managers then assume leadership roles, overseeing large-scale data management projects, developing data management strategies, and mentoring junior staff, ultimately positioning themselves for senior leadership or specialized roles in data science, regulatory affairs, or clinical operations.
