JBCPL is widely committed to manufacturing a range of innovative specialty products that include various pharmaceutical dosage forms like tablets, injectable (vials, ampoules, form fill seal), creams & ointments, lozenges, herbal liquids, and capsules.

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JBCPL has its headquarters in India’s financial capital, Mumbai. With a domestic sales force of 1,000 people, 17 internationally approved state of the art manufacturing units, a Research and Development Centre, and subsidiaries abroad, the organization is continually enhancing value for its shareholders.

In India and International markets, JBCPL is also known as Unique Pharmaceutical Laboratories and is a division of JBCPL.

Position: Sr Executive – Clinical Trials

Location: Prabhadevi, Mumbai, Maharashtra

Job Description:

  • Assisting in the review of documents related to BA/BE study & clinical trial.
  • Drafting Protocol, informed consent forms, case report forms, Investigator Brochure study report, and any other clinical trial-related documents.
  • Tracking and updating the latest guidelines & Amendments pertaining to clinical trial / BA-BE study.
  • Track and report on the progress of study including site activation, patient enrolment, and monitoring visits.
  • Identify, select, and monitor the performance of investigational sites for clinical studies.
  • To negotiate and manage the budget and payments for investigative sites, if applicable.
  • Perform clinical data review of data listings and summary tables, including query generation.
  • Assisting in drafting documents required for dossier filling such as CTD module, SmPC, PI, etc.
  • Assisting in pharma-co-vigilance related activity (drafting PSUR, responding to patient complaints, etc).
  • Oversee performance of CROs, CRFs monitoring, to ensure compliance with the study protocol and in accordance with SOPs and Protocol.

Qualification: B.Pharma/M.Pharma/M.Sc (Bio)

Experience: 3-4 Years

Salary: Negotiable

Contact Details:

chetan.prajapati@jbcpl.com, corporate@jbcpl.com

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