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.

Essential Duties and Responsibilities: 

• 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.
• 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.
• Trend study control performance and study outcome.
• Review study data to ensure activities were executed according to protocol requirements SOP approved timelines and GLP expectations.

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):

Masters degree in a science-related (Pharmacology / Toxicology would be a best fit) field with 5-7 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
• Should able to sit for long periods as per role requirement

Remote Work :

No

Employment Type :

Full-time