Principal Clinical Data Manager

About the Role

The Principal Clinical Data Manager (PCDM) is primarily responsible for providing in-depth guidance as Subject Matter Expert in Clinical Data Management (CDM) best practices, use of Electronic Data Capture (EDC) systems and other software applications that interface with EDC (e.g. IWRS, ePRO), use of eCRF standards and libraries, and creation of data listings, data visualisations and dashboards in order to undertake efficient data inspection and discrepancy (query) management.

The PCDP will lead in developing company conventions and standards applicable to the CDM area, as well as initiatives to streamline CDM processes, in close collaboration with the Manager CDM and Manager Clinical Applications & Compliance. The PCDM will mentor junior staff, develop training materials, participate in industry forums, and may undertake internal compliance assessments on request of Biometrics Management.

The PCDM can act as Project Manager CDM looking after one client account and being the client's point of contact for all CDM matters regarding the client's clinical project(s), technically and financially. The PCDM interacts with clients, Project Managers, internal Biometrics functions and other project stakeholders within and outside of Biometrics.

1. Projects/Clinical Studies

• Participate in project meetings and client meetings as Subject Matter Expert for Clinical Data Management (CDM) providing advice on all aspects of CDM processes, systems and tools in view of client's business objectives, regulatory requirements and Novotech best practices.
• Contribute to protocol development or review client's protocol in terms of schedule of assessments, consistency with assessments' descriptions and internal company standards of the corresponding CRFs, timing of assessments, implicit assessments (e.g. fed conditions require food intake CRF), Adverse Event definitions versus CDASH, validated questionnaires, laboratory data, etc.
• Advise other Biometrics functions, Project Management and clients with respect to the application of generic and disease specific CRF libraries and data dictionaries based on CDASH and SDTM.

2. Team

• Participate in industry forums (conferences, professional association committee work etc.) and providing training on CDM related topics to Biometrics and wider Novotech organisation.
• Participate in CDM team meetings and Biometrics department meetings.
• Train and mentor new and existing CDM team members in SOPs, software applications, CRF libraries, and CDM best practices
• Undertake internal compliance assessment upon request of Line Manager or Biometrics Management and participate in audits.

3. Software Tools

• Monitor and advise Line Manager on new capabilities of EDC platforms and related clinical trial applications from a CDM perspective by participating in online user forums and attending workshops/ meetings/conferences as appropriate.
• Develop generic and disease specific CDISC derived standards for eCRFs in collaboration with other functions within Biometrics establishing eCRF and edit check libraries for re-use across studies.
• Evaluate new CDM methodologies and practices - possibly involving new software applications - for generating efficiencies and productivity increases in CDM in consultation with the Line Manager.

4. CDM Processes and SOPs

• Lead the development and updating of SOPs and best practices, process improvement, quality control and governance related to all CDM matters.
• Adhere to applicable regulatory guidelines and Novotech's corporate policies and procedures, and to SOPs, Forms, Libraries and Best Practices related to CDM.
• Contribute to infrastructural (non-clinical) process improvement initiatives as Subject Matter Expert for CDM.