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Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM), Program Manager / Director

Location: United States

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.

#LI-BC1

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