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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Operations Management / Process Analysis |
| EmploymentType | Full-time |
Your responsibilities:Your responsibilities include, but are not limited to:1. Act as the project leader of the clinical trial (internal and external team) and execute trial in accordance with project strategy 2. Contribute clinical research and operational expertise in the development of clinical trial design; 3. Providing input to clinical development plans regarding timelines and study feasibility 4. Responsible for the efficient and compliant execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment, data consistency) 5. 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. 6. 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. 7. Perform monitoring / co-monitoring visits according to SOPs 8. Prepare clinical trial medication forecast 9. Planning and tracking of trial budget in line with company financial reporting 10. Proactive knowledge sharing within department, SDC and Sandoz 11. 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) 12. Active participation in project teams, and contributions to formulation development 13. Contribute to global clinical development activities (e.g. process harmonization, knowledge sharing, participation in working groups) 14. Contribute as agreed with line manager to other clinical related tasks like clinical due diligence Minimum requirements 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 analyze, discuss, interpret and present scientific data Strong communication and organizational skills Proven people management skills with demonstrated expertise in working on teams Flexible to travelWhy consider Novartis 750 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,
Keyskills :
salesinsurance recruitmentmarketing recruitingpeople management skills life sciencesdue diligence