Study Director - LCMS

Opportunity 

Are you a highly experienced and driven Study Director with LCMS experience seeking a new opportunity? Would you like to work for a fast growing global company that prides itself on delivering quality results every time, for every project?  Do you have experience working with clients managing assigned studies from start up to close out? If  the answer is yes, then we would like to hear from you.

For candidates based interstate or overseas, relocation assistance to Adelaide, South Australia is on offer and visa sponsorship for you and your family if you are situated overseas.

About you

• 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.

Key responsibilities 

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. 

Responsibilities include:

• 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.
• Communicate with internal stakeholders 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, operations, management.
• Update and review Analytical Laboratory Methods (ALM).
• Input to Standard Operating Procedures (SOPs) relevant to Study Director role.
• 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.

Why Agilex Biolabs

As the leading bioanalytical laboratory for clinical trials, Agilex Biolabs is 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
• Training & development opportunities
• Flexibility and work-life balance
• A culture which respects and values it's employees.

How to apply

To join our team, please submit your CV along with a cover letter outlining your skills and experience - please submit as one word or PDF document.