Study Director

7 days ago

City of West Torrens, Australia Agilex Biolabs Full time
About the Role

We are seeking an experienced 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 managing assigned studies from start to close, ensuring timely delivery and high-quality results.

Key Responsibilities
  • Manage studies to ensure timelines are set appropriately and achieved.
  • Communicate effectively with external stakeholders, including clients and regulatory authorities.
  • Ensure the scientific integrity and regulatory compliance of study data.
  • Troubleshoot scientific issues and liaise with internal stakeholders as needed.
  • Update and review Analytical Laboratory Methods (ALMs) and Standard Operating Procedures (SOPs).
  • Coordinate with operations and R&D to ensure smooth transition of methods into validation.
Requirements
  • 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.
  • 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.
About Agilex Biolabs

We are a global leader in bioanalytical services, known for our commitment to quality and innovation. Our team is dedicated to providing high-quality bioanalytical services, and we are seeking a Study Director who shares our values and passion for excellence.

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