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.
Minimum Qualifications & Experience
- Graduate in a clinical or life sciences related field. At least eight years of experience
- Clinical Data Management (CDM) of which 4 years working in a Senior position in the
- pharmaceutical or CRO industry.
- In-depth knowledge of all CDM related activities including use of EDC systems and other data capture applications, inspection and reconciliation of clinical and external data, and tracking and reporting on progress of CDM activities.
- Excellent understanding of regulations applicable to the CDM area as well as Good Data Management Practices, CDM and Trial Master File, and regulations regarding Electronic Data Capture (EDC) systems and validation.
Responsibilities:
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.
- Support CDM staff with (complex) CDM study requirements throughout the entire study lifecycle, from protocol development to database lock and decommissioning. This includes but is not limited to:
- Advise and peer review, as required, on the configuration. validation documentation and training requirements of non-EDC applications that need to interface with the EDC system,
-Advise and peer review, as required, regarding the specification documents for the design of the clinical study database and additional applications (e.g. ePRO), for data reporting and visualization to facilitate data inspection, data reconciliation, clinical/medical review and CDM status reporting,
-Advise and peer review, as required, regarding all key CDM documents for the Study Conduct, Database Lock and Decommissioning stages.
- Undertake all Senior CDM tasks of the Start-up, Study Conduct, Database Lock and Decommissioning stages, in the role of Project CDM, and liaise with client, Project Manager, Line Manager and other stakeholders. This includes but is not limited to:
-Establish CDM project plan and project manage all CDM deliverables across Study Start-up, Study Conduct, Database Lock and Decommissioning stages,
-Undertake financial management of the project including monthly unit reconciliation (actualization), invoicing and forecasting,
-Coordinate the CDM scope and impact assessment in terms of timelines and cost for change orders (change management),
-Ensure the CDM project files and CDM project TMF are up-to-date and audit ready at any point during the study,
-Ensure compliance with CDM SOPs and data standards over the lifecycle of the project,
-Maintain study documentation, programs and files within project files and maintain timesheets.
2.Team
- Participate in industry forums (conferences, professional association committee work etc.) and providing training on CDM related topics to Biometrics and wider Novotech organization. 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.
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 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 contacting you regarding your application.
