Group Leader – Study Support Specialist (GLP studies – Product Safety Labs)

Position Summary:

To better support the Study Director function and allow them to focus on scientific oversight and regulatory accountability. A dedicated leader ideally a toxicologist who would oversee a group of support staff responsible for providing the following services:

Essential Duties and Responsibilities: 

• Team leadership qualities (coaching and mentoring of staff)
• Managing 4-5 team members along with assigned duties
• Collaborate with lab staff to gather study requirements test article information and study design details necessary for study initiation laboratory assignment and resource planning.
• Conduct quality control reviews of laboratory data worksheets and study records to ensure accuracy completeness consistency and readiness for Study Director review which will include long-term and complex studies generating extensive datasets.
• Monitor study milestones deliverables and critical path activities to proactively identify risks communicate potential delays and support on-time completion of client commitments and regulatory deadlines.
• Coordinate the development review revision and issuance of study protocols amendments and associated study documentation in accordance with GLP requirements and internal procedures.
• Maintain study documentation and tracking systems ensuring study files remain audit-ready and compliant with applicable quality standards throughout the study lifecycle.
• Assist with the preparation of shipping documentation and return authorizations for test articles samples and retained materials while obtaining reviewing and maintaining chain-of-custody records and shipment tracking information.
• Support Study Directors with scheduling study logistics sample management and cross-functional communication among laboratory quality assurance and/or project management.
• Track study-related actions deviations data requests and outstanding documentation to ensure timely resolution and complete study records.
• Assist with the compilation review and organization of study data packages for report generation archival and regulatory inspection readiness.
• Trend study control performance and study outcome.
• Provide technical writing support for projects which may include generating shell documents and tables of data that was collected over the course of a study.
• Review study data to ensure activities were executed according to protocol requirements SOP approved timelines and GLP expectations.
• Participate in process improvement initiatives aimed at enhancing study execution efficiency data quality compliance and client satisfaction.

Qualifications :

Basic Minimum Qualifications (BMQ): 

To perform this job successfully the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge skill or ability required.

Education/Experience (BMQ):

• Preferred education: M.S. Ph.D. DABT-equivalent background or other advanced degree/training relevant to toxicology or preclinical safety assessment.  At least 10 years of experience in Pre-clinical studies / trials IND enabling studies IND filing and with knowledge of regulatory requirements (GLP).
• At a minimum masters degree in a science-related (Toxicology would be a best fit) field.  12-15 years of experience in Pre-clinical studies / trials IND enabling studies IND filing and with knowledge of regulatory requirements (GLP).

Additional Information :

Abilities and/or Skills:

• Honest Dependable Demonstrated Ability to Self-Manage
• Detail Oriented Accurate Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking Good Reasoning Ability
• Strong communication including verbal writing and presentation skills
• Dedication to quality ethics and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel 

All candidate CVs and cover letters will be reviewed however please note that we are not always able to respond to every expression of interest submitted.  

Remote Work :

No

Employment Type :

Full-time