Clinical Project Associate Information

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Dr. Reddy's Laboratories Ltd

Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company focused on providing medicines through its three business segments: Global Generics segment, Pharmaceutical Services and Active Ingredients (PSAI) segment and Proprietary Products segment. The company was founded by Dr. Anji Reddy, who had previously worked in the publicly owned Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and ov... Read More

Address	White House, Block 'c' 5th Floor No 6-3-1192/1, Kundanbagh, Begumpet, Begumpet, Hyderabad, Andhra Pradesh 500016
Website	www.drreddys.com/
Holding	No Holding Details

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Clinical Project Associate

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 lifecycle 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 deliverables 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.