769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Job Description
- Post: Clinical Development Associate
- Qualification: MSc or PhD in Life Sciences (pharmacy or medicine) Fluent in English (oral and written)
- Experienced: Minimum 3 years of experience in direct clinical development or associated fields
- Location: Hyderabad, AP
Minimum requirements
• MSc or PhD in Life Sciences (pharmacy or medicine) Fluent in English (oral and written)
• Minimum 3 years of experience in direct clinical development or associated fields
• Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials preferred
• Knowledge of GCP and regulatory requirements related to assigned area
• Experience in medical/scientific writing skills. Computer literacy
• Strong communication and organizational skills
• Proven expertise in working on teams. Flexible to travel
Sandoz aspires to become the leading and most valued generics company.
At Sandoz, we are planning capital expenditures of several hundred million USD over the next 5 years to expand production capacity in key markets for small molecules and biopharma
Your responsibilities include, but are not limited to:
• Act as the Study Manager of the clinical trial (internal and external team) and execute trial in accordance with project strategy. Contribute clinical research and operational support in the development of clinical trial design;
• 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 documents like the Clinical Study Protocol, Report, Investigator Brochure, 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
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