Clinical Project Manager

At Charles River, we are passionate about improving the quality of people's lives. When you join our global family, you will help create healthier lives for millions of patients and their families.

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

** Job Overview*
* Provide high-level project management and operational support for clinical studies across Safety Assessment sites to ensure high quality customer service. Serve as the central point of coordination between site Operations, Scientific teams, and the Sponsor. Manage the internal and external communication for study meetings, workflow and technical details, and deliverables necessary to meet study timelines.

ESSENTIAL DUTIES AND 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.

** Job Qualifications*
* +

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:

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.

+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

+ Certification/Licensure:
Project Management certification preferred.

+ 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.

COMPENSATION INFO:

The pay range for this position is $67,000 - $72,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

** Education*
* Four-year degree required

** About Safety Assessment*
* Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art…