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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 and scientific integrity.
- Review and ensure the accuracy of study data, including the review of all runs.
- Troubleshoot scientific issues by liaising with Research & Development, operations, and management.
- Update and review Analytical Laboratory Methods (ALMs) and Standard Operating Procedures (SOPs) relevant to the Study Director role.
- Coordinate with operations and the Lead Analyst to ensure operational progression of studies.
- Liaise with R&D 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 for clinical trials. We pride ourselves on delivering high-quality results and investing in the latest technology. Our employees are our most valuable asset, and we strive to create a warm and welcoming work environment that respects and values diversity. We promote a collaborative and fun team environment that offers:
- Honest and open communication.
- Collaborative teamwork.
- Supportive and caring environment.
- Mutual respect.
- Flexibility and work-life balance.
- A culture that respects and values its employees.
To be considered for this role, please submit your CV and a cover letter outlining your skills and experience. We will only contact you directly if you are successful in being shortlisted for the next stage of our recruitment process. We may keep your resume on file for future employment opportunities, but we recommend that you continue to look for our future job advertisements and apply to those you feel you are suited to.
