Opportunity for M.Pharm as Clinical Operations Manager at Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post : Clinical Operations Manager
• Works as Clinical Project manager for complex generic products (including Respiratory, Transdermal and Injectables) and differentiated products for developed as well as Emerging markets.
• Planning and execution of clinical studies, monitoring and conducting the clinical development operation activities (protocol finalisation, site selection, site monitoring, study plans, patient recruitment, Data Management, Biostatistics, study report finalisation) and resolving complex issues with respect to conduct of clinical and patient based pharmacokinetic studies
• Work closely with product development teams, preclinical & clinical, regulatory and medical teams for successful execution of clinical development of projects
• Develop clinical study synopsis and protocol after obtaining inputs from medical and other relevant stakeholders
• Identify CROs for outsourcing of clinical trials for complex generic and differentiated products. Plan regular meetings with CROs for outsourced projects to ensure projects are on track. Ensure adequate sponsor oversight, monitoring and quality of the outsourced projects
• Track milestones consistently with pre-clinical and clinical stakeholders as well as CROs, and take accountability for successful achievement of milestones
• Devise clinical monitoring plan to ensure optimal oversight and monitoring of clinical studies
• Liaise with clinical investigators at various stages of clinical studies to ensure the successful conduct of these studies
• Liaise with Ethics Committees and Regulatory bodies for obtaining timely approvals of studies
• Prepare and maintain project updates and present in internal review meetings
Experience : 7 to 10 Years
Qualification : M.Pharm
Location : IPDO, Dr. Reddys Labs, Bachupally, Hyderabad, Telangana, India
Industry Type : Pharma/ Healthcare/ Clinical research
Skills Required : Clinical trials, Respiratory clinical development, PK in Patients studies
End Date : 15th August, 2020.
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