job title: clinical data manager(novotech)

Job Description

Brief Position Description:

The core responsibility for this position is as a member of Novotech’s Data Management group. The Clinical Data Manager’s (CDM’s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP).

Minimum Qualifications & Experience:

Graduate in a clinical or life sciences related field. At least four to eight years' experience in a similar role working in the research, pharmaceutical industry or a related field.

Responsibilities:

Member of the project team reporting to the Project Manager for integrated projects, the Clinical Data Manager is responsible for planning, conducting and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs.

1. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated.

2. May act as Project Manager for “stand-alone” data management projects.

3. Participates in project team meetings as required.

4. Input into the preparation of RFP’s in liaison with BD and the clinical team.

5. Liaison with the project and client for preparing and maintaining Data Management Plans.