Assistant Manager – CR & PV

3 - 7 Years
Mumbai

Job Description

Clinical Trials
1. To identify potential investigators/sites and conduct site feasibility
2. To conduct site evaluation visits
3. To facilitate and coordinate with investigator and site for EC submissions and approval
4. To prepare and review site master file, trial master file and Annexure 1
5. Coordinate with investigator and sites for investigator meeting and assist in planning of same
6. To prepare and review budget for clinical trial based on individuals site budget
7. To coordinate with study sites for query resolutions and problems if any
8. To plan and conduct Site Initiation Visits.
9. To prepare Site Initiation Visit reports and communicate to site about visit details in applicable timelines.
10. To plan, conduct routine monitoring visits. To prepare report and communicate site with follow up letter in applicable timelines
11. To obtain weekly updates from sites for the on-going trials
12. To coordinate with data management team and investigator/site for timely DCF resolutions
13. To calculate IP requirement for site/study
14. To plan, conduct close out visits. To prepare report and communicate site with follow up letter in applicable timelines.
15. To arrange for archival of trial documents at site
16. To maintain excel sheet of compliance for clinical research department
17. To maintain updated site wise documents in common folder
18. To maintain updated formats in common folder
19. To maintain training file and CV updated for department records
20. Identify areas where self-training which would help performance and suggest relevant workshops/training programs held outside the company
21. To assist in SOP preparation for clinical research department activities
22. To identify (if required) and coordinate with vendors for supply of study related goods and services

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:R&D

Role:Clinical Research Manager

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile

Bharat Serums and Vaccines Limited

Bharat Serums And Vaccines Limited is one of the fastest growing bio pharmaceutical companies in India.

BSV established in 1971 by the late Dr. Vinod Daftary researches, develops, manufactures, and markets injectable biological, pharmaceutical, and biotechnology products.

BSV's products portfolio includes plasma derivatives, monoclonals, fertility hormones, antifungals, anaesthetics, cardiovascular drugs, and equine immunoglobulin /antitoxins.

The R&D of drug delivery systems, biotechnology/recombinant therapeutics, and biological/equine products; In addition, BSV offers products in the areas of gynaecology, assisted reproductive technology, critical care, emergency medicine, neurology, nephrology, haematology, and urology.

The company provides its products to retail outlets and hospitals through distributors primarily in India, as well as in the Asia Pacific, the Russian Federation, CIS countries, Latin America, Africa, and internationally.

BSV is amongst the top 10 Biotech companies in India. The Company has in its portfolio over 25 brands. The company has over 750 employees selling its products across the country. Our brands are marketed all over India and exported to over 45 countries across the world

We have an open and entrepreneurial culture, with each of our employees taking on significant responsibility in each activity of our value chain, be it in terms of research & development, manufacturing, quality, sales & marketing, distribution, business development or organisation building.
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Contact Company:Bharat Serums and Vaccines Limited

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