1.Clinical trial Execution / monitoring: Preparation / review and submission of Clinical study documents to regulatory, Clinical trial execution and monitoring for differentiated products and product intended for India regulatory, Quality checking of the documents during monitoring, cross-verifying the data recorded in Case Report Form with the source document, reviewing informed consent form, reviewing patient eligibility. Quality oversight and Remote Monitoring of patient based bio-equivalence / clinical-endpoint studies. In case of any discrepancy reporting to Medical Monitor, Team leader In Order to ensure trial is conducted as per protocol and ICH-GCP guidelines.
2.Identification of new investigators: Identifying new investigator for the trial from different database, contacts with sites. Doing proper feasibility to the site. In Oder to ensure the site recruits the patient properly and conduct studies as per the guidelines and protocol.
3.Budget negotiation: Negotiating the trial budget with the sites to maintain uniformity within sites In order to ensure smooth budget negotiation process.
4.Post marketing surveillance: Preparation of protocol, CRF for the marketed product to gather safety information post launch of product as per regulatory requirement. Do CRF validation and submit data to data management team In Order To ensure Post marketing surveillance of approved products.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Clinical ResearchClinical Research AssociateSite MonitoringClinical Trials
Education:UG -, MBBS – Medicine, B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
Doctorate – Doctorate Not Required
Dr. Reddyâ€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products â€” Dr. Reddyâ€™s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com
Recruiter Name:Not Mentioned
Contact Company:Dr Reddys Laboratories Ltd