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Study Director
2 months ago
We are seeking a highly experienced and driven Study Director to join our team at Agilex Biolabs, a leading bioanalytical laboratory for clinical trials. As a Study Director, you will be responsible for overseeing assigned studies, ensuring timely completion, and maintaining scientific integrity and regulatory compliance.
Key Responsibilities- Manage studies to ensure timelines are set appropriately and achieved.
- Communicate effectively with external stakeholders, including clients and regulatory bodies.
- Collaborate with internal stakeholders to ensure project progression.
- Ensure the scientific integrity and regulatory compliance of study data.
- Troubleshoot scientific issues and liaise with relevant groups.
- Update and review Analytical Laboratory Methods (ALMs) and Standard Operating Procedures (SOPs).
- Coordinate with operations and lead analysts to ensure operational progression of studies.
- Liaise with Research & Development to ensure smooth transition of methods into validation.
- Ordinary degree in life sciences.
- Minimum 5 years experience in regulated Bio-analysis, ideally in a pharmaceutical or CRO environment.
- Minimum of 2 years work experience Study Directing within a GCP/GLP laboratory is essential.
- Demonstrated experience in communicating with clients on high-level science issues.
- Experience with Laboratory Information Management Systems (LIMS), preferably Watson.
- Experience in LCMS method development.
- Proven ability to review SOPs and ALMs.
- Demonstrate efficient problem-solving and scientific data interpretation abilities.
- Ability to work effectively both in isolation and as part of a team.
- Proven ability to deliver tasks on time with a high degree of accuracy.
- Demonstrated initiative, trust, and reliability and the ability to work unsupervised.
- Willingness to work in and be supportive of a positive and dynamic team culture.
- High level of written and verbal communication skills.
Agilex Biolabs is a global leader in bioanalytical services, recognized for its commitment to quality, innovation, and employee satisfaction. We offer a collaborative and supportive work environment, with opportunities for professional growth and development.
How to ApplyTo be considered for this exciting opportunity, please submit your CV and a cover letter outlining your relevant experience and qualifications. We look forward to reviewing your application.
