For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Overview
Do you have expertise in bioanalysis, and a desire to manage Clinical Projects?
Do you want to work for a company that can positively impact patients globally?
Charles River Laboratories are excited to be recruiting for two Clinical Project Managers to join our Global Laboratory Sciences function.
These are remotes role but with expectation for ad hoc travel to our Tranent Edinburgh site (up to 10% travel).
These roles would suit candidates with a strong background in bioanalysis coupled with experience of managing scientific projects either at another CRO/biotech. You will also have excellent communication skills, with the ability to build and maintain strong working relationships with internal and external stakeholders to deliver on client projects.
Job Description
What you’ll be doing:
• 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 Laboratory Operations, 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 and Experience:
• Education: BSc/MSc 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: Significant industry-led laboratory experience in bioanalysis in a pharmaceutical or contract research laboratory environment, with working understanding of GLP and/or GCP standards. Laboratory operations and/or client management experience preferred.
• 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.
• Candidates must have full and permanent Right to Work in the UK as we are unable to provide sponsorship for these roles.
The salary range for the role is £35,000 - £40,000/annum + bonus + benefits. Please note that the salary varies 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 300 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.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to fostering a sense of belonging and work daily in this direction.
