Clinical Study Director

Job Overview

An opportunity has arisen for the position of Study Director, working within the Clinical Section of the Research & Development Department.

Main Duties and Responsibilities:

The Study Director will work in a quality focus environment regulated to GLP standards. 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 a Quality focus environment in accordance with Regulatory requirements (e.g. FDA/EMA), the principles of GLP, GCP, and SOPs in operation within the Research & Development Department. 

The successful candidate will be responsible for a managing a range of study designs, including:

• Pharmacokinetic/Bioequivalence studies.
• Residue depletion studies.
• Target Animal Safety.
• Laboratory Studies (dissolution and characterisation).
• Clinical studies (artificial and natural infections).

Essential Criteria

• Educated to a minimum of degree level in a relevant life science discipline.
• Flexible and be able to prioritise and time manage efficiently.
• Proven commitment to work to defined deadlines.
• Excellent written and verbal communication.
• Have good interpersonal skills.
• Be assertive yet tactful.
• Possess a strong team spirit with the ability to work as part of a multi-disciplined team.
• Have a full UK driving licence.

Desirable Criteria

• Have previous experience in the role.
• Have previously worked in a GLP/GMP environment.
• Have previous experience in in vitro experiments/models.
• Previous experience in a laboratory with knowledge of bioanalytical method testing.
• Have understanding of relevant regulatory guidelines.

Duration: Full time, Permanent

Location: Newry, Co. Down

Benefits:

Free Life Assurance
Company Pension Scheme
Healthcare cash plan
32 days annual leave
Wedding Leave
Company Sick Pay
Employee well-being initiatives
Employee Assistance Programme
On-site free parking
Canteen Facilities
Employee Perks scheme
Employee Recognition scheme
Career development opportunities

Contact: recruitment@norbrook.co.uk

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.