Note: The job is a remote job and is open to candidates in USA. Charles River Laboratories is a contract research organization providing drug development, safety assessment, and clinical laboratory services. The Clinical Project Manager provides high-level project management and operational support for clinical studies, coordinating site Operations, Scientific teams, Sponsors, communications, timelines, logistics, risks, and deliverables.
Responsibilities
- In conjunction with internal and external study team members, develop and manage individual study timelines and milestones according to the Sponsor's needs
- In collaboration with Client Services and Business Coordination teams, support the development and review of study proposals / SOWs (including ASOWs) to ensure alignment with Sponsor requirements and internal capabilities
- Review Sponsor supplied study documents (e.g. laboratory manuals, protocols, and data transfer agreements) to confirm scope of work
- Coordinate with site Operations and/or Scientist to provide program scheduling updates and timeline requirements
- Coordinate, facilitate, and lead routine and ad hoc project update meetings, teleconferences, status reports, and study kick-off meetings
- Record detailed meeting minutes, distribute minutes with clear assigned action items and deliverables
- Track study logistics (e.g. sample shipments, counts) through coordination with site Operations to ensure study timelines are maintained
- Support of billing and contract reconciliation, ensuring discrepancies are resolved and expected work is aligned to available contracted billable units
- Mitigate study risks through identification of roadblocks and potential problems. Resolve and/or escalate issues to site and/or global management as appropriate
- Develop or contribute to study communication plans as applicable and ensure timely communication with all stakeholders
- Utilize applicable software to organize study minutes, notes, and spreadsheets to track study activities, action items, and milestones
- Create diagrams and process maps to enhance communication of issues and potential solutions
- Independently perform non-routine projects to optimize communication, tools, and information platforms shared between the site(s) and Sponsors
- Provide feedback to global client managers for reporting key performance metrics and program status updates, including successes and risks
- Use and continually develop leadership skills
- Contribute to special projects that support global Clinical Lab Sciences initiatives
- Perform all other related duties as assigned
Skills
- * 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
- * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- * Other: Proven working experience in project management, excellent written and verbal communication skills for client-facing and internal interactions, strong organizational skills including attention to detail and multitasking skills, proficient working knowledge of Microsoft Office, knowledge of regulatory requirements of study types assigned, as well as SOPs, GLPs, and GCPs as appropriate
- Four-year degree required
- * Experience: A minimum of 5 years previous directly related GLP or GCP laboratory experience in a pharmaceutical or contract research laboratory environment
- Laboratory operations and/or client management experience preferred
- * Certification/Licensure: Project Management certification preferred
Benefits
- Bonus/incentives based on performance
- 401K
- Paid time off
- Stock purchase program
- Health and wellness coverage
- Employee and family wellbeing support programs
- Work life balance flexibility
Company Overview
Company H1B Sponsorship