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 Summary
We are seeking an Operations Program Manager (Lab Sciences) for our Safety Assessment site located Reno, Nevada.
The following are responsibilities related to the Operations Program Manager (Lab Sciences)
Experienced in study program management with strong leadership, customer service, and client facing communication skills, preferably in a bioanalytical science setting. Reviews and interprets sponsor supplied study documents to confirm scopes of work. Prepare communication plans and study trackers to ensure timely communication and study program visibility for all stakeholders. Coordinate with laboratory scheduling to provide program scheduling updates and timeline requirements. Lead and facilitate internal and external facing meetings, teleconferences, and laboratory pre-study meetings, including transcription of meeting minutes action item assignment, and follow-up. Develop spreadsheets, diagrams, and process maps to document needs. Identify and resolve roadblocks and potential problems, with appropriate escalation to senior management as appropriate. May provide supplementary support for global client managers for site specific study needs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

• In conjunction with scientific and operational staff, develop and manage individual study and overall project timelines and milestones according to the Sponsor’s needs.
• Review Sponsor supplied study documents (e.g. laboratory manuals, protocols, and data transfer agreements) to confirm scope of work.
• Coordinate with laboratory scheduling staff to provide program scheduling updates and timeline requirements.
• Coordinate, facilitate, and lead routine and ad hoc project update meetings, teleconferences, status reports, Sponsor kick-off meetings, and laboratory pre-study meetings.
• Transcribe detailed meeting minutes, assign and track action items and deliverables.
• Identify roadblocks and potential problems. Resolve and/or escalate issues to senior management as appropriate.
• Develop a communication plan for each study and ensure timely communication with all stakeholders.
• Develop spreadsheets, diagrams and process maps to document needs.
• Assist with management of QA data audits to ensure audits are completed on-time.
• Work with Client Services and Project Coordination staff to ensure SOW and ASOW documents accurately reflect the work being conducted.
• Independently perform special non-routine projects to optimize communication tools and information platforms shared between departments.
• Where applicable provide supplementary support to global client managers for Nevada site specific study needs.
• Use and continually develop leadership skills.
• Perform all other related duties as assigned.

Job Qualifications
The following are minimum qualifications related to the Operations Program Manager (Lab Sciences) position:

• 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 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 Testing Facility SOPs, GLPs, and GCPs as appropriate.

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.

Job Type: Full-time

Pay: $80,000.00 per year

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