Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Development Manager
• Act as the project leader of the clinical trial (internal and external team) and execute trial in accordance with project strategy
• Contribute clinical research and operational expertise in the development of clinical trial design;
• Providing input to clinical development plans regarding timelines and study feasibility
• Responsible for the efficient and compliant execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment, data consistency)
• Responsible for the preparation and/or review of clinical program documents like the Clinical Study Protocol, Report, Investigator Brochure, Annual Report, Briefing Books, and, if applicable, publication.
• Assure the quality of trial performance and trial documentation by implementing standardized working procedures according to SOPs, GCP and regulatory requirements and by verifying the continual compliance of each trial team member with these procedures. Resolve deviations to procedures by remedial action and training.
• Perform monitoring / co-monitoring visits according to SOPs. Prepare clinical trial medication forecast
• Planning and tracking of trial budget in line with company financial reporting. Proactive knowledge sharing within department, SDC and Sandoz
• Contribute to preparation of relevant parts of registration documents and interactions with health authorities in context of clinical studies (e.g. scientific advices, deficiencies letters)
• Active participation in project teams, and contributions to formulation development
• Contribute to global clinical development activities (e.g. process harmonization, knowledge sharing, participation in working groups)
• Contribute as agreed with line manager to other clinical related tasks like clinical due diligence.
• MSc or PhD in Life Sciences, Fluent in English (oral and written).
• Minimum 5 years’ experience in clinical development or associated fields
• Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials
• Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
• Solid medical/scientific writing skills. Computer literacy
• Ability to analyse, discuss, interpret and present scientific data
• Strong communication and organizational skills
• Proven people management skills with demonstrated expertise in working on teams
• Flexible to travel
Experience : 5 year
Qualification : M.Sc or Ph.D
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 15th March, 2020
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