• Ensure standardization of procedures for CPU operations as per in- house SOP's and applicable regulatory guidelines. • Responsible for preparation and/or review of relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements. • Preparation, review, provide scientific inputs in the development of Protocol’s/ICD /CSR/FORBE and other study documents. • Coordinating with EC for approval of study documents. • Co-ordinating with designated pharmacist for receipt, verification, dispensing, retention of IP’s and ensure timely and prompt intimation to the sponsor for any discrepancies. • Co-ordination with BD/project management/sponsor for proper slotting of Clinical Studies. • Ensure the readiness of facilities with respect to administrative aspects (personnel, equipment’s, machines etc.), ICU along with emergency drugs, availability of an ambulance during conduct of study. • AE’s/SAE’s: Identification of AEs/SAEs and prompt management & timely notification of SAE to the EC/ sponsor/regulatory. • Review of clinical study reports, REMS, abbreviated clinical study reports, e CTD (Electronic Common Technical Document) Module- 2 & Module- 5 as per ICH GCP clinical and non-clinical overviews, safety reports, Investigator's Brochure (IB), periodic safety update reports as per applicable guidelines, and client specifications

More about this Doctor job

Mediclin Clinical Services is aggressively hiring for the job profile of Doctor at Lucknow in Balaganj locality. Kindly go through the FAQs below to get all answers related to the given job. 1. How much salary can I expect? Ans. You can expect a minimum salary of 0 INR and can go up to 25,000 INR. The salary offered will depend on your skills, experience and performance in the interview. 2. What is the eligibility criteria to apply for this job? Ans. The candidate should have completed Diploma degree and people who have 0 to 31 years are eligible to apply for this job. You can apply for more jobs in Lucknow to get hired quickly. 3. Is there any specific skill required for this job? Ans. The candidate should have Basic English skills and sound communication skills for this job. 4. Who can apply for this job? Ans. Both Male and Female candidates can apply for this job. 5. Is it a work from home job? Ans. No, it’s not a work from home job and can’t be done online. You can explore and apply for other work from home jobs in Lucknow at apna. 6. Are there any charges or deposits required while applying for the role or while joining? Ans. No work-related deposit needs to be made during your employment with the company. 7. How can I apply for this job? Ans. Go to the apna app and apply for this job. Click on the apply button and call HR directly to schedule your interview. 8. What is the last date to apply? Ans. The last date to apply for this job is 02-Dec-2023. For more details, download apna app and find Part Time jobs in Lucknow. Through apna, you can find jobs in 74 cities across India. Join NOW!