Novartis Clinical Trial Leader Job Opening – Apply Online
Associate Clinical Trial Leader
Job ID: 394655BR
Date: Mar 18, 2024
Location: India
About the Role: Your responsibilities include, but are not limited to:
- Leading studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned.
- Supporting the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL).
- Contributing to the development of clinical protocols, amendments, and related documents.
- Supporting the development of clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
- Supporting the global multidisciplinary CTT to ensure all trial results are met according to timelines, budget, quality standards, and operational procedures.
- Attending CTT meetings, assisting in reporting study progress and issues.
- Supporting ongoing review and cleaning of the clinical trial data, support final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
- Coordinating the real-time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging, and biomarker data.
- Ensuring accuracy of trial information in all trial databases and tracking systems.
- Attending relevant meetings to support ongoing execution of clinical trial and program level activities.
- Ensuring that program specific standards/activities are applied to the clinical trial.
- Developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors.
- Handling work with external vendors in collaboration with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s).
Diversity & Inclusion / EEO: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements:
- Bachelor degree or equivalent experience or equivalent education/degree qualification in life science/healthcare required if accompanied by at least 2 years of involvement with clinical study planning, execution, reporting and publishing activities.
- Good communication, organization and tracking skills.
- Experience in Good Clinical Practice; basic knowledge of scientific principles.
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