Associate Clinical Trial Leader

Associate Clinical Trial Leader at Novartis – Life Sciences Apply Now!

Associate Clinical Trial Leader at Novartis – Life Sciences Apply Now! Interested and eligible applicants can check out all of the details on the same below:

Associate Clinical Trial Leader

Job ID REQ-10011054

Jun 09, 2024

India

Summary

Responsible for supporting, under the guidance of the Lead Clinical Trial Leader and/or Clinical Trial Leader (CTL) and the Clinical Program Leader (CPL), all aspects of TCO clinical trial(s) as assigned.

About the Role

Major accountabilities:

  • May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned.
  • Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical Program Leader (CPL): contribute to the development of clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processes.
  • Contribute, with the support of a CTL/Lead CTL and the CPL, to the development of the clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities’ questions.
  • Under the guidance of the CTL/Lead CTL, support the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: attend CTT meetings, assist in report study progress and issues.
  • In collaboration with the CPL, support the CTL/Lead CTL, in the 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.
  • Under the supervision of the CTL/Lead CTL coordinate the real-time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.
  • Responsible for the accuracy of trial information in all trial databases and tracking systems.
  • Attend relevant meetings to support ongoing execution of clinical trial and program-level activities.
  • Under the guidance of a CTL/Lead CTL ensure that program-specific standards/activities (e.g., CRFs, UAT testing, database specifications, Data Handling plan, outsourcing specifications including imaging, biomarkers, PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.
  • Under the guidance of the CTL/Lead CTL develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation 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).
  • Support the implementation of best practices and standards for trial management, including sharing lessons learned.

Key performance indicators:

Support of CTL/CTLs on the planning, executing, and closing of early phase trials on time and within budget. Adherence with guidance of GCP/ICH to ensure high-quality trial conduct. Support of ongoing data review to promote trial decisions and strategic planning.

Minimum Requirements:

  • Advanced degree or equivalent education/degree in life science/healthcare or
  • Bachelor degree 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 (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program).

Work Experience:

  • Good communication, organization, and tracking skills.
  • Basic knowledge of Good Clinical Practice; basic knowledge of scientific principles.

Skills:

  • Clinical Trials
  • Conflict Management
  • Contract Management
  • Effective Communication
  • Financial Analysis
  • Negotiation Skills

APPLY ONLINE HERE

Keywords: Associate Clinical Trial Leader, Clinical Trials, GCP, ICH, Novartis, Healthcare. Associate Clinical Trial Leader at Novartis – Life Sciences Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram.

Shekhar
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.