Clinical Study Director

6 days ago

Co Armagh Northern Ireland, United Kingdom Norbrook Full time
Job ref: CSD111024 Job type: Permanent Location: Newry Closing date: Friday 25 Oct 2024 17:00 The Clinical Study Director will work in a quality focus environment regulated to GLP standards.

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

The successful candidate will lead, manage data and report non-clinical and clinical studies for safety and efficacy trials for animal health products.

The successful candidate will be responsible for the planning, conduct and reporting of studies in an organised and timely manner, and in accordance with Regulatory requirements (e.g.

FDA/EMA), the principles of GLP, GCP, and SOPs in operation within the Research & Development Department.

The Clinical Study Director will be the single point of control for a range of study deigns, including Pharmacokinetic/Bioequivalence studies, residue determination, Target Animal Safety, Clinical studies (artificial and natural infections).

The Study Director is responsible for ensuring the scientific, administrative and regulatory aspects of the study are controlled.

Key activities include: Study protocol design and approval.

Overseeing data collection and analysis is conducted and reported in line with the approved SOPs, Method and Protocol.

Coordinate with study personnel to keep informed of study progress.

Receive and evaluate data and phase reports for inclusion in the Final Study Report.

Ensuring that the study is conducted in compliance with the relevant regulatory standard and Drawing the final overall conclusions of the study.

Essential Criteria: Educated to a minimum of degree level (or equivalent) in a relevant life science discipline.

Experience in scientific report writing and review.

Ability to work independently.

Experience in managing 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 prioritise and deliver to project deadlines.

Demonstrated ability to work as part of a multi-disciplined team.

Have a full UK driving licence.

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.

Applicants who are unable to provide this proof will not be considered.

We regret that applications received after the closing date and time will not be accepted.

Contact: Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit.

In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.

To Apply Please forward your CV via the APPLY Now button below.

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