Job Description

Job Title: Clinical Data Manager

Location: Durham, NC

Duration: 09 Months contract (Potential temp to Perm)

Payrate: $55/hr. - $65/hr. (Depending on experience)

Shift: 1st shift, Mon-Fri , 8am-4:30pm

Start Date: ASAP

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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