Project Manager, Clinical Study Report (CSR) Appendices, Novartis dedicated, home-based in UK

We are currently looking for a detail-oriented and organized Project Manager with expertise in Clinical Study Report (CSR) Appendices. This role primarily involves authoring CSR appendices compiling clinical study data and related documents, tracking and coordinating all appendices. The successful candidate will work closely with various study team members across several countries, ensuring each clinical study report appendices are accurate, comprehensive, and prepared in a timely manner to ensure successful publication.

If you enjoy collaborating across line functions and want to strengthen your skillsets around clinical study report appendices authoring, electronic Trial Master Files (eTMF) oversight and being part of a submission & multi-disciplinary team, this role is a great fit for you.

Key Responsibilities:

• Manage and oversee the organization and preparation of appendices to Clinical Study Reports (CSRs).

• Collaborate with cross-functional teams including the clinical, regulatory, and data management teams to gather all necessary data and documents.

• Review clinical trial data and any other relevant documentation to ensure appendices are accurate and complete.

• Coordinate with the medical writing team for accurate incorporation of the appendices into the final clinical study reports.

• Ensure adherence to ICH-GCP, regulatory guidelines, SOPs, and project specific guidelines in preparing appendices.

• Manage timelines for appendices preparation and ensure timely delivery.

• Quality control of the appendices to confirm accuracy and completeness.

• Handle any queries related to CSR appendices from both internal and external stakeholders.

• Manage eTMF section related to CSR ensue all documents are uploaded on time with right quality

Qualifications:

• Bachelor’s degree in a life science, pharmacy, or related health field; advanced degree preferred.

• At least 3-5 years of experience in clinical research or related field.

• Strong knowledge of clinical trial processes and ICH-GCP guidelines related to CSR.

• Experience in CSR appendices authoring and quality control.

• Experience of handling eTMF.

• Excellent organizational and project management skills.

• Strong attention to detail and excellent written and good communication skills.

• Proficient computer skills, particularly with MS Office Suite.

• Demonstrated ability to work effectively in a individual contributor environment, and manage multiple projects concurrently.