Job Description

Clinical Data Manager

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).

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 team and client for preparing and maintaining Data
   Management Plans.
6. Responsible for all aspects of data management including:
   • Design and review of database structure, validation rules and consistency checks.
   • Operation of Clinical Data Management software for data entry of clinical trial
     results.
   • 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.
7. Supervision and training support for junior and contract Data Management staff as
   required.
8. Adherence to company Quality Policy and procedures as applicable to carrying out
   job responsibilities.
9. Identification of and participation in process improvement initiatives, as required.
10. Perform accurate study financial projections and maintain monthly project financials.
11. Ensure changes in scope are identified and actioned accordingly
12. Provide expert assistance and input into internal cross-functional projects including
    clinical research and regulatory affairs, as assigned.
13. Project management of internal IT-based company projects as assigned (e.g. intranet
    development, client database applications etc.).
14. Active contribution to company business development initiatives, including
    involvement in the implementation of data management plans for business
    development in the company in general.
15. Participation in industry forum (conferences, professional association committee
    work etc) as a means of professional development as well as promotion of
    Novotech’s image in industry.

Minimum Qualifications & Experience:

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

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.