Sandoz, a Novartis division is inviting applications from eligible candidates for the post of Clinical Development Associate for its Hyderabad location.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives.
About the Job
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
- 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
How to Apply?
Interested applicants can apply for the post through this link.