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.