About this role
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. 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):
Master’s 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).
Abilities and/or Skills:
Honest, Dependable, Demonstrated Ability to Self-ManageDetail Oriented, Accurate, PreciseStrong Math SkillsStrong Organizational SkillsLogical Thinking, Good Reasoning AbilityStrong communication including verbal, writing, and presentation skillsDedication to quality, ethics, and customer serviceAbility to handle personal stressMental and emotional stability and maturityMotivation to excelShould able to sit for long periods as per role requirement