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).