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Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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