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Clinical Research Assoc I

Date: Nov 10, 2021

Location: Navi Mumbai, IN, 400706

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

  1. Regulatory/ethics submission of CT as per timelines and to ensure regulatory documents are available, complete and current.
  2. In coordination with the project manager and/or medical monitor, perform study site selection visits. Participate in/conduct investigator’s meeting and site initiation visits.
  3. To perform regular monitoring visits to site and prepare monitoring reports
  4. To ensure the compliance to ICH-GCP guidelines, local & international   regulations (i.e. DCGI, FDA) and applicable SOPs.
  5. To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements. 
  6. Evaluates the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
  7. Conduct site close out and assure appropriate archival of controlled documents. 
  8. Maintain contacts outside the regular onsite visits, by appropriate communication means, to regulate or to motivate work to be performed by investigators or their staff. These contacts are always recorded and regularly transmitted to the project manager/project team. 

Qualifications

M. Pharmacy in Pharmacology or B. Pharmacy plus M. Sc. in clinical research

Experience Required - 2 - 4 Years

Function

Research & Development

Sub Function

Clinical Development

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.