Provide primary resource and project management for Non-Clinical studies in Laboratory Sciences to ensure compliance with protocols, phase plans, and applicable SOP’s. Act as a liaison between multiple departments and the Sponsor to ensure Non-Clinical study milestones are appropriately communicated, scheduled, and executed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensure study activities are performed in compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs) regulations.
- Perform study preparation activities including but not limited to organizing internal and/or external facing prestudy meetings, assist in identifying supply needs, and developing and implementing Study Specific Procedures (as appropriate).
- Assist in the development and maintenance of non-clinical resource management and data tracking tools.
- Assist in the resource schedule determination of all study related activities. Act as a liaison between adjacent departments (e.g. Client Services, Resource Scheduling, Scientists, Study Directors, etc.) to ensure feasibility and timelines for potential work, and completing milestones for scheduled work.
- Regularly communicate with Sponsor representatives (e.g. the Sponsor, or third party laboratories/vendors) regarding study activities, including teleconferencing.
- Review Sponsor supplied study documents (E.g. laboratory manuals, protocols, and preparation instructions) and provide recommendations on technical and logistical aspects of their designs.
- Participate in preparing responses to both internal and external quality assurance audits.
- Manage and coordinate project timelines, resource coordination, and prioritization of assigned studies in conjunction with laboratory operations management and/or assigned lead analyst.
- Adhere to current health and safety regulations.
- Perform all other related duties as assigned.
- Education: Bachelor’s Degree (B.S./B.A) or equivalent in biology, chemistry/pharmacy, or similar lab environment or must have demonstrated full knowledge of competencies and positive performance at the previous level.
- Experience: Three years previous directly related GLP or GCP laboratory experience in a pharmaceutical or contract laboratory environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Exceptional analytical and problem solving capabilities. Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and GLPs, as appropriate. Fully proficient in technical skills and the operation of data collection equipment. Must be able to perform effectively as a team member, accurately record data, follow verbal and written instructions, communicate effectively and interact in a professional manner with management, coworkers and sponsors. Excellent written and verbal communication skills. Able to prioritize work and meet deadlines. High level of proficiency in the use of standard software and be able to quickly learn and utilize computer programs as needed.
Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet