www.drreddys.com Dr.Reddy's Laboratories Ltd Hyderabad : Clinical Project Associate

[ijt.dolora@gmail.com]

Dr.Reddy's Laboratories Ltd, Hyderabad
Company web address : http://www.drreddys.com/

Clinical Project Associate
Experience: 1 to 4 yrs.
Job Description:
1. Assist Project Lead in all aspects of the Clinical Trial Execution, including tracking of performance, drafting responses to and providing clarifications for queries relating to CT operations for assigned projects.
2. Manage internal communication loops and processes to assist Project Lead in overall CT execution and management processes, including escalation of issues, and routine trial dashboard review
3. Responsible for the setup, quality and maintenance of the electronic Trial Master Files (TMF) in accordance with Company SOPs.
4. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Company SOPs, GCP and ICH Guidelines.
5. Work with Project Lead, and Regulatory Affairs personnel to ensure all regulatory documents are maintained during the life cycle of any assigned project
6. Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc.) and responsible for the follow up to collect outstanding documents.
7. Provides quality overview, integrate reviews and conduct consistency check on all CT related documents such as ICFs, IBs, Protocols
8. Coordinates Key Stakeholder (internal and external) meetings related to protocol development, and for CT execution.
9. Work with Project Lead and CRO to conduct CT related activities at Site such as feasibility analysis, site selection, initiation visits, and monitoring visits.
10. Assist Project Lead and CRO in liaison with Medical Resources to address Investigator, Site, IRB, Regulatory queries.
11. Responsible for providing operational level detailing of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverable are met across assigned sites.
12. Work with Business Managers to ensure invoices are tracked and approved in liaison with Project Lead. Responsible for First level checks for project related invoices
13. Assists the project team in preparation for audits/ inspections.
14. Responsible for providing routine updates to Project Lead on Trial performance, Site Supplies.
15. Work with Supply Chain System for ensuring Clinical trial supplies reach distribution channels on-time.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Key skills: Clinical Research, Clinical Trials, audits, Project
Education Qualification : UG - B.Pharma - Pharmacy AND PG - M.Pharma - Pharmacy AND Doctorate - Doctorate Not Required

Send a resume mail to talent@drreddys.com

Contact Us :
Human Resources
Dr. Reddy's Laboratories Ltd.
8-2-337, Road No. 3
Banjara Hills, Hyderabad
Hyderabad - 500 034, INDIA

[sangeeta.tarlekar]

Resume
Sangeeta Tarlekar
Email : sangeeta.tarlekar AT rediffmail.com

Educational Qualification :
- Passed B.A.M.S from Pune University, in 1995
I am persuing the course of Proficiency programme in Pharmacovigilance[Distance Participation] from Bioinformatics institute of India delhi.
- Passed H. S. C. from S. B. College of Science, Aurangabad, Aurangabad Divisional Board, with First Class in 1990
- Passed S. S. C. from S. B. Highschool, Aurangabad, Aurangabad Divisional Board, with Distinction in 1988

Major Professional Achievements :
- Successfully conducted cancer screening camps in remote locations in Ratnagiri and Sindhudurg districts of Maharashtra.
- Experience of handling Emergencies, Gynace and Obs. cases, Skin and V.D cases, and General Medicince

Work Experience :
- Working presently as self -employed General Practitioner in Savjal for 10 years
- Associated with Matrumandir Hospital Devrukh as Chief Medical officer handling their poly clinic hospital (40beds) for 2 years
- Associated with BKLW Hospital for cancer screeing project, in collaboration with Tata Cancer Hospital Mumbai.

Personal Details :
Date of Birth : 9th Feb 1972
Marital status : Married.
Languages Known : English, Hindi, Marathi
Hobbies : Reading, Traveling

Date : Sangeeta Tarlekar (Ponde)