Study Director

4 weeks ago

City of West Torrens, Australia Agilex Biolabs Full time

Job Title: Study Director - Bioanalytical Leadership Role

Company: Agilex Biolabs

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 studies from start to finish, ensuring timely delivery and scientific integrity of study data.

Key Responsibilities:

  • Manage study timelines, ensuring that company and external stakeholder requirements are met.
  • Communicate effectively with external stakeholders, including clients and Clinical Research Organisations (CROs).
  • Collaborate with internal stakeholders, including operations, Quality Assurance (QA), and management, to ensure project progression.
  • Ensure the scientific integrity and regulatory compliance of study data.
  • Troubleshoot scientific issues and coordinate with Research & Development (R&D) and operations to ensure smooth study progression.
  • Update and review Analytical Laboratory Methods (ALM) and contribute to Standard Operating Procedures (SOPs) relevant to the Study Director role.

Requirements:

  • Ordinary degree in life sciences.
  • Minimum 5 years experience in regulated Bio-analysis, preferably 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.
  • Demonstrated efficiency in problem-solving and scientific data interpretation.
  • Ability to work effectively 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, with the ability to work unsupervised.
  • Willingness to work in 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.

About Agilex Biolabs:

As a global leader in bioanalytical services, Agilex Biolabs offers a collaborative and supportive work environment. We value our employees' integrity, expertise, and hard work, and we strive to provide a culture that respects and celebrates diversity.

How to Apply:

To be considered for this role, please submit your CV and a cover letter outlining your skills and experience. We will contact you directly if you are shortlisted for the next stage of our recruitment process.

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