Study Director

23 hours ago


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

We are seeking a highly experienced Study Director to join our team at Agilex Biolabs. 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 stakeholders (clients, Clinical Research Organisations (CROs)) and internal stakeholders (operations, Quality Assurance (QA), management)
  • Ensure the scientific integrity and regulatory compliance of study data by reviewing all runs
  • Troubleshoot scientific issues by liaising with appropriate groups (Research & Development (R&D), operations, management)
  • 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
  • Update and review Analytical Laboratory Methods (ALM)
  • Input to Standard Operating Procedures (SOPs) relevant to Study Director role
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 as a Study Director
  • Demonstrated experience in communicating with clients on high level science issues
  • 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
  • Intermediate Word and Excel experience
  • Experience with Laboratory Information Management Systems (LIMS), preferably Watson (desirable)
  • Experience with immunoassay development (desirable)
About Agilex Biolabs

Agilex Biolabs is a leading bioanalytical laboratory for clinical trials, known globally for its continued investment in the latest technology and for attracting some of the leading scientists from Australia and around the world.

We recognise that our people are our most valuable asset. It is through our employees' integrity, expertise, and hard work that we can provide high-quality bioanalytical services.

We provide a warm and welcoming work environment for all our employees, we believe that it is critical to the achievement of our organisational objectives that we encourage and maintain a culture which respects, values, and celebrates the wonderful diversity of our people.

We promote a collaborative, and fun team environment where you will experience: Honest and open communication Collaborative teamwork Supportive and caring environment Mutual respect Flexibility and work-life balance A culture which respects and values its employees

How to Apply

To be considered for this role, please submit your CV along with a cover letter outlining your skills and experience. Please note that due to the high volume of applications we receive, we will only contact you directly should you be successful in being shortlisted for the next stage of our recruitment process.

We may keep your resume on file for future employment opportunities, as advertised on Seek, however recommend that you continue to look for our future job advertisements and encourage you to apply to those you feel you are suited to.

If you do not wish your details to be held for future opportunities, please contact us directly to have this removed.


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