Project Planner (science background)

• Perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Embody the behaviors and performance characteristics as described in our core values
• Develop knowledge of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
• Develop effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, and externally with Regulators
• Develop critical thinking, troubleshooting and time management skills aligned with the needs of the operational area
• Ensures that operational area is clean and inspection ready at all times
• Actively collaborates with technical and scientific staff, internal groups, Business Development and Leadership at a defined site and/or department as required
• Actively participates in Sponsor meetings, taking and distributing meeting minutes to all participants in a timely manner
• Actively supports full Sponsor programs, across all internal scientific departments at a site with minimal oversight
• Effectively reviews project contracts with minimal oversight and ensures project is managed in accordance with defined scope in each contract as required by operational area
• In collaboration with the Bioanalytical Scientist (BPI), actively ensures that projects are managed to completion, on time and within budget with minimal oversight
• Effectively monitors studies from start to finish with minimal oversight, updating Project Management system in a timely manner
• Develop ability to assist Bioanalytical Scientist (BPI) to communicate with internal support teams to ensure all project deliverables (long- and short-term) are conveyed, adhered to, and delivered on time
• Actively ensures that project billing is completed in a timely manner and is correct based on the contract with oversight
• Efficiently and accurately assigns study numbers and populates data with the Project Management system as required by operational area
• Actively reviews study protocol, study documents, and method to ensure study details within the Project Management system are accurate as required by operational area
• Effectively partners with Bioanalytical Scientists (BPI) and management to increase customer satisfaction and strengthen Sponsor relationships
• Actively updates and communications changes to internally the scope of work, along with associated budget and timeline impacts as required by operational area
• Effectively facilitates revenue recognition and forecasting for assigned projects with minimal oversight

BA/BS; all experiences will be evaluated

Experience: minimum 0-2 years related experience in project management in a regulated laboratory or research environment. Experience in a CRO preferred.

Other: Excellent written and verbal communication skills, ability to multi-task, excellent organizational skills, and attention to detail. Must possess analytical thinking and problem-solving skills. Ability to prioritize and re-evaluate priorities as situations change. Working knowledge of computer software (MS Office, MS Teams, Excel, and database experience preferred).