Clinical Study Director

1 week ago


Newry, United Kingdom Norbrook Full time
Job Title: Clinical Study Director

We are seeking a highly skilled and experienced Clinical Study Director to join our Research and Development team at Norbrook Laboratories Limited.

About the Role

The successful candidate will be responsible for leading and managing data and reporting non-clinical and clinical studies for safety and efficacy trials for animal health products. This will involve planning, conducting, and reporting studies in an organized and timely manner, in accordance with regulatory requirements (e.g. FDA/EMA), the principles of GLP, GCP, and SOPs in operation within the Research & Development Department.

Key Responsibilities
  • Study protocol design and approval
  • Overseeing data collection and analysis, and reporting in line with approved SOPs, methods, and protocols
  • Coordinating with study personnel to ensure study progress
  • Receiving and evaluating data and phase reports for inclusion in the Final Study Report
  • Ensuring compliance with relevant regulatory standards
  • Drawing final overall conclusions of the study
Requirements
  • Minimum of degree level (or equivalent) in a relevant life science discipline
  • Experience in scientific report writing and review
  • Ability to work independently and manage multiple projects
  • Excellent written and verbal communication skills
  • Ability to communicate assertively in a professional manner
  • Flexible with a proven ability to adapt as projects progress through development
  • Excellent time management skills
  • Strong interpersonal skills
  • A strong team spirit
  • Proven ability to prioritize and deliver to project deadlines
  • Demonstrated ability to work as part of a multi-disciplined team
  • Full UK driving license
Desirable Criteria
  • Previous experience in a similar role
  • Experience in deviation impact assessment
  • Previous experience in a GLP/GMP environment
  • Previous experience in a laboratory with knowledge of bioanalytical method testing
  • An understanding of relevant regulatory guidelines
Additional Information

Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. We regret that applications received after the closing date and time will not be accepted.



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