Study Director

1 month ago

City of West Torrens, Australia Agilex Biolabs Pty Ltd Full time
About Agilex Biolabs

We are a leading bioanalytical laboratory for clinical trials, known globally for our continued investment in the latest technology and for attracting top scientists from around the world.

Job Description

We are seeking a highly experienced and driven Study Director with LCMS experience to join our team. As a Study Director, you will be responsible for managing studies to ensure timelines are set appropriately and achieved, communicating effectively with external and internal stakeholders, and ensuring the scientific integrity and regulatory compliance of study data.

Key Responsibilities
  • Manage studies to ensure timelines are set appropriately and achieved
  • Communicate effectively with external and internal stakeholders
  • Ensure the scientific integrity and regulatory compliance of study data
  • Troubleshoot scientific issues by liaising with appropriate groups
  • Update and review Analytical Laboratory Methods (ALM)
  • Input to Standard Operating Procedures (SOPs) relevant to 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
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 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
What We Offer
  • Relocation assistance
  • Visa sponsorship
  • A warm and welcoming work environment
  • Collaborative and fun team environment
  • Honest and open communication
  • Training & development opportunities
  • Flexibility and work-life balance
How to Apply

To apply, please submit your CV along with a cover letter outlining your skills and experience. We will only contact you directly should you be successful in being shortlisted for the next stage of our recruitment process.

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