Novartis Clinical Trial Leader Job Opening - Apply Online
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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.

Click here to apply

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Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.