Clinical Data Manager

 

 

The person in this position will support the Biometrics team across multiple oncology studies.  This person must have a high attention to detail and be able to work across multiple projects.

Responsibilities

General Responsibilities include:

Primary responsibilities of the Clinical Data Manager are to perform and monitor ongoing data review for all clinical trials sponsored by the company and contracted to outside CROs.  Responsibilities also include maintaining oversight of ongoing data cleaning to support data deliverables.

 

Specific Responsibilities include:

  • Perform ongoing patient profile review

  • Assist in study start-up activities (CRF design, UAT, edit checks review, etc.)

  • Review protocols to ensure the data collection, database and reporting requirements can be met

  • Perform data trend analysis and oversee data cleaning activities

  • Assist in review of data management related documents prior to approval (data management plan, CRF Completion Guidelines, edit check specifications, coding guidelines, vendor management plans, etc.)

  • Review CRF metrics reports against project data deliverables

  • Maintain internal data management timelines

  • Participate in internal team meetings and provide data management updates on assigned studies

  • Provide vendor oversight as necessary. Acts as primary liaison with third party data vendors, EDC vendors.

‪Education / Experience / Skills

  • Minimum BA/BS in scientific or health-related field.

  • Minimum of 3 to 5 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.  Oncology trial experience strongly preferred and global/international experience a plus.

  • Proficiency with different data collection systems (e.g., eCOS, Rave).

  • Excellent communication (verbal and writing).

  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.

  • Experienced using Microsoft Office applications (Word, Excel, etc.)

  • Strong organizational skills and ability to prioritize tasks. 

  • Ability to work independently with minimal supervision.