Clinical Project Associate opening for M.Pharmacy people in Dr.Reddy...R

Dr. Reddy"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 - Dr. Reddy"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

Designation	Clinical Project Associate
Job Description	Should have working knowledge of ICH- GCP regulations and clinical protocols. Key Responsibilities: 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. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Company SOPs, GCP and ICH Guidelines. 4. Work with Project Lead, and Regulatory Affairs personnel to ensure all regulatory documents are maintained during the lifecycle of any assigned project 5. 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. 6. Provides quality overview, integrate reviews and conduct consistency check on all CT related documents such as ICFs, IBs, Protocols 7. Coordinates Key Stakeholder (internal and external) meetings related to protocol development, and for CT execution. 8. Work with Project Lead and CRO to conduct CT related activities at Site such as feasibility analysis, site selection, initiation visits, and monitoring visits. 9. Assist Project Lead and CRO in liaison with Medical Resources to address Investigator, Site, IRB, Regulatory queries. 10. Responsible for providing operational level detailing of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites. 11. 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 12. Assists the project team in preparation for audits/ inspections. 13. Responsible for providing routine updates to Project Lead on Trial performance, Site Supplies. 14. Work with Supply Chain System for ensuring Clinical trial supplies reach distribution channels on-time
Desired Profile	Please refer to the Job description above
Experience	2 - 4 Years
Industry Type	Pharma / Biotech / Clinical Research
Role	Clinical Research Associate/Scientist
Functional Area	Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education	UG - Any Graduate - Any Specialization  PG - M.Sc - Any Specialization, M.Pharma - Pharmacy
Location	Hyderabad / Secunderabad
Keywords	Clinical Research, clinical research associate, clinical trial
Contact	Talent Acquisition Team  Dr Reddys Laboratories Ltd
Website	http://www.drreddys.com
Job Posted	28 Nov