Preclinical Study Manager, Research and Early Development, Hybrid Cambridge, MA

Preclinical Study Manager, Research and Early Development, Hybrid Cambridge, MA
  The Opportunity We are seeking a Preclinical Study Manager to oversee externally contracted in vivo and in vitro studies supporting research and early development programs. This role will collaborate with internal research and development teams to design, manage, track, and report preclinical studies conducted through external Contract Research Organizations (CROs).

The Study Manager will help assess CRO capabilities, prepare requests for proposals, evaluate bids and timelines, coordinate study awards, and ensure outsourced studies remain aligned with approved budgets and development plans. The role will also support protocol development, study monitoring, data reporting, documentation, and long-term financial forecasting.

The ideal candidate is highly organized, detail-oriented, and comfortable managing multiple studies, vendors, timelines, and priorities in a fast-paced biotechnology or pharmaceutical environment.

Key Responsibilities

• Develop and submit study concepts and requests for proposals to qualified CROs
• Obtain and evaluate CRO proposals, budgets, and timelines
• Negotiate study scope, costs, and timelines as appropriate
• Coordinate with Toxicology, DMPK, Bioanalysis, Biology, Pathology, CMC, Program Management, Finance, Legal, Procurement, Supply Chain, and Sample Management teams
• Prepare statements of work and support CRO contract review and processing
• Assist with protocol development, amendments, animal orders, test article projections, and shipments
• Maintain complete and organized study files, including schedules, contracts, protocols, correspondence, and reports
• Track internal and external report timelines and study deliverables
• Coordinate test article supplies, orders, characterization, stability testing, and retesting
• Conduct CRO site visits at key study milestones
• Participate in pre-study, operational, progress, and pre-reporting meetings with CRO partners
• Support budget forecasting, contract awards, invoice review, and financial tracking
• Manage outsourced GLP and non-GLP preclinical studies, including pharmacokinetic, toxicology, and biodistribution studies
• Serve as a primary contact for CRO partners and provide ongoing study oversight
• Troubleshoot issues, communicate changes, and track study activities across vendors and project teams
• Participate in CRO selection and qualification activities
• Maintain integrated schedules for internal and external preclinical studies
• Help coordinate meetings, resources, workloads, and study priorities
• Support process improvement initiatives
• Ensure studies are conducted in accordance with applicable global regulatory guidelines
• Take on additional projects as needed

Qualifications

• Ph.D. in Biology, Toxicology, or a related field preferred
• Bachelor’s degree in Biology, Toxicology, or a related discipline with at least six years of relevant experience in biotechnology, pharmaceuticals, or a CRO environment
• Previous study direction or study coordination experience within a CRO is highly preferred
• Experience managing outsourced preclinical studies, preferably in a GLP environment
• Knowledge of global regulatory guidelines, including ICH, GLP, and OECD standards
• Experience with laboratory animal research studies is a plus
• Working knowledge of invoicing, accounting, budgeting, or contract management
• Strong attention to detail and ability to critically review study documentation
• Excellent organizational, multitasking, time-management, and program-management skills
• Experience with project scheduling and study-tracking tools
• Strong written and verbal communication skills
• Ability to work effectively with internal stakeholders, external vendors, and cross-functional project teams
• Ability to manage changing priorities, timelines, and deliverables in a fast-paced environment
• Willingness to travel periodically for CRO site visits and study-related meetings

Additional Information This role may require onsite work and periodic domestic travel, with occasional international travel depending on business needs. The position involves managing multiple preclinical studies and CRO relationships across research and early development programs.


 

Estimated Min Rate: $70.00
Estimated Max Rate: $100.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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