Job title: Clinical Research Assoc I
Company: Teva Pharmaceuticals
Job description: 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!
- Regulatory/ethics submission of CT as per timelines and to ensure regulatory documents are available, complete and current.
- 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.
- To identify, define, coordinate and conduct site study training.
- To perform regular monitoring visits to site and prepare monitoring reports
- To ensure the compliance to ICH-GCP guidelines, local & international regulations (i.e. DCGI, FDA) and applicable SOPs.
- To verify the case report forms and source data according to the monitoring plan
- To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
- 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.
- To resolve all data queries or other study related queries from the site within timeframe.
- Conduct site close out and assure appropriate archival of controlled documents.
- Organize travel and movements to the best cost efficiency and in respect of the general rules and procedures of the company.
- Doctorate, Master’s or Bachelor’s Degree. Major course of study must be Science or Health-related. (i.e. M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc along with some diploma in clinical research etc)
- Understanding of clinical research process and ICH GCP
- Basic understanding of the drug development process
- Prior on site monitoring experience of 2 to 5 years on Phase I/II/III clinical trials in the capacity of CRA either in CRO or a bio-pharmaceutical company.
- Requires basic managerial skills to effectively manage time and execution of defined objectives or tasks independently.
Research & Development
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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.
Location: Bangalore, Karnataka
Job date: Fri, 11 Mar 2022 03:16:28 GMT
Apply for the job now!