Novartis Clinical Development Associate
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Novartis Clinical Development Associate Job For Life Sciences

Novartis Clinical Development Associate Job For Life Sciences. Novartis Jobs. Novartis MSc Life Sciences Jobs. Novartis Life Sciences Clinical Development Associate Recruitment, Apply Online. Interested and eligible applicants can check out all of the details on the same below

Name of the Post – Clinical Development Associate

Job ID – 345193BR

Country – India

Work Location – Hyderabad, AP

Company/Legal Entity – Nov Hltcr Shared Services Ind

Functional Area – Research & Development

Job Type – Full Time

Employment Type – Regular

Shift Work  -No

Early Talent – No

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 the trial in accordance with project strategy. Contribute clinical research and operational support in the development of the 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 from 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 the department, SDC and Sandoz
  • Contribute to the preparation of relevant parts of registration documents and interactions with health authorities in the context of clinical studies (e.g. scientific advice, deficiencies letters). Active participation in project teams

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

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