About the role

Job Description Summary

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. May contribute to process improvements, cross-functional collaboration, and knowledge sharing.

Job Description

Major accountabilities:

Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).
Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
Maintain and share up to date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously enhance expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies.
Contribute to the finalization and management of clinical, regulatory and study-related documents in scope of role such as study protocols, patient-facing documents, etc., by ensuring documents are complete, accurate, and consistent.
Contribute and/or maintain ownership of the management and finalization of clinical, regulatory, and study-related documents such as study protocols, patient-facing documents, Clinical Study Report (CSR) appendices, etc., by providing support to draft, review, and ensure completeness, accuracy, and consistency of these documents, as needed.
Support and/or lead interactions and communications with relevant functions including Novartis country organizations to prepare, collect, and/or compile relevant documents, and timely follow-up on pending actions as necessary.
Support and/or lead external communication such as newsletter development, external meeting organization.

Minimum Requirements:

At least 2+ years’ experience in clinical trial/
development.
Adept organizational skills and quality mindset with
attention to detail.
Strong communicator with demonstrated interpersonal
skills. Basic presentation skills and ability to mentor/ train small groups.
Ability to successfully interact with a wide range of
people, including global teams, different cultures, diverse
experience backgrounds, etc. Ability to work in a team as well as independently if required and to manage multiple priorities

Skills Desired

Clinical Research, Clinical Trials, Data Integrity, Learning Design, Risk Monitoring

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

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About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.