Senior Clinical Data Manager

Novotech Global•Charleston, SC

42d•$110,000 - $145,000

About The Position

The core responsibility for this position is as a member of Novotech’ s Data Management group. The Senior Clinical Data Manager’s (SCDM’s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP). As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as well as training for junior colleagues

Requirements

Graduate in a clinical or life sciences related field.
At least eight to ten 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 Senior 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.
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.
May function as Project Manager for “stand-alone” data management projects.
Input into the preparation of RFPs in liaison with BD and the clinical team.
Liaison with the project team and client for preparing and maintaining Data Management Plans.
Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks Operation of Clinical Data Management Systems All data cleaning/validation tasks Development of all key Data Management Documents
Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders.
Liaison with external service providers on Data Management projects as appropriate
Assist in the development of protocols as required.
Supervision and training support for junior and contract Data Management staff as required.