Clinical Data Manager

Highly Competitive Salary
  1. Permanent
  2. Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
Durham, USA
Posting date: 06 Jan 2021
CR.BC.34838

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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