Study Director - Immunoassay
Clinical Life Sciences
Location Adelaide, Australia
Salary Competitive, plus generous relocation package
Study Director – Immunoassay
An exciting opportunity has arisen to join a growing CRO in Adelaide, Australia. The role is within a Regulated Bioanalytical laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. As Study Director – Immunoassay (IA), you will be responsible for performing Study Director functions for immunoassay-based validations and analysis.
- Perform the role of Study Director and/or Principal Investigator with overarching responsibility for assigned studies, with support from trained and experienced Study Directors as required.
- Manage studies to ensure timelines are firstly set appropriately taking into account, company and external stakeholder requirements, and once set, ensure timelines are achieved.
- Communicate effectively with external stakeholders (i.e. clients, Clinical Research Organisations (CROs)).
- Communicate with internal stakeholders (i.e. operations, Quality Assurance (QA), management) to ensure project progression.
- Ensure the scientific integrity and regulatory compliance of study data by (at minimum) the review of all runs.
- Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
- Coordinate with operations and, in particular, the Lead Analyst to ensure operational progression of studies.
- Liaise with R&D to ensure smooth transition of methods into validation.
- Input to Standard Operating Procedures (SOPs) relevant to Study Director role.
- Able to be assigned Deputy Study Director duties as required.
- Commitment to internal training programs.
- The accountabilities as specified above may be altered in accordance with the changing requirements of the position.
Experience and qualifications
Ideally candidates will be educated to degree level (or equivalent) in relevant scientific discipline. Candidates will possess significant relevant experience as a study director/senior scientist, with industry experience managing multiple clinical studies at any one time. Other key experience includes:
- 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.
This is a great opportunity to join a successful organisation in a period of growth. There is full support available for visas for you and your family, and significant relocation assistance on offer. If this sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.