Description
About the Role:
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 Valuable 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.

Qualifications & Experience:
- Graduate degree in a clinical or life sciences related field
- 8+ years of experience in a similar role within the research, pharmaceutical industry, or a related domain

Technical Skills:
- Hands-on experience with EDC systems: Medidata Rave and Veeva CDMS

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 collaborates with PM to ensure appropriate mitigation and contingencies are initiated
- May act as Project Manager for “stand-alone” data management projects.
- 3. Participates in project team meetings as required.
- Input into the preparation of RFPs in liaison with BD and the clinical team.
- 5. Liaison with the project team and client for preparing and maintaining Data Management Plans.
- 6. Responsible for all aspects of data management including:

a. Design and review of database structure, validation rules and consistency ch

📌 Senior Clinical Data Manager (India)
🏢 Novotech
📍 India