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 proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Responsibilities

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.

Qualifications

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.