Clinical Project Manager

About the role

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.
• Cook up with site Operations and/or Scientist to provide program scheduling updates and timeline requirements.
• Cook up, 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.
• 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.

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 facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit www.criver.com.