Clinical Data Manager

Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Durham, NC.

Job Responsibilities:

• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

Skills and Requirements:

• 8+ years' experience
• Bachelors and/or a combination of related experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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