A growing biotechnology company is seeking a Nonclinical Research & Study Management professional to support the coordination and execution of preclinical research studies. This individual will work closely with internal research scientists and external CRO partners to oversee study activities, manage timelines and deliverables, and ensure projects progress efficiently.
This is a hands‑on role that combines a strong scientific research background with study coordination and CRO management responsibilities. The majority of projects will be in vivo focused, making this an excellent opportunity for someone with experience in preclinical research who is looking to take on greater ownership of study management and external partnerships.
Key Responsibilities
- Oversee the planning, coordination, and execution of nonclinical studies conducted internally and through external CRO partners.
- Serve as the primary point of contact for CROs, managing day‑to‑day communications and study activities.
- Coordinate closely with internal research scientists to ensure study objectives, timelines, and deliverables are met.
- Lead study kickoff meetings and coordinate ongoing project discussions with internal teams and external partners.
- Track study milestones, timelines, sample logistics, and overall progress across multiple projects.
- Review and contribute to the development and finalization of study protocols, amendments, and final reports.
- Proactively identify and resolve study‑related issues in collaboration with CROs and internal stakeholders.
- Support data compilation and reporting, including tables, figures, and listings.
- Monitor CRO budgets and invoices, coordinating milestone payments and approvals.
- Communicate study updates, potential risks, and timeline considerations to internal stakeholders.
Qualifications
- Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.
- 3+ years of hands‑on research experience within biotechnology, pharmaceutical, CRO, or academic research environments.
- Experience coordinating nonclinical or preclinical studies and working directly with CRO partners.
- Strong organizational and project coordination skills, with the ability to manage multiple studies and competing priorities.
- Excellent communication skills and the ability to work cross‑functionally with scientific teams and external vendors.
Preferred Qualifications:
- Hands‑on in vivo research experience, including animal studies.
- Familiarity with GLP‑regulated studies and associated documentation.
- Knowledge of IACUC protocols and animal welfare requirements.
- Experience reviewing nonclinical study protocols, amendments, and reports.
- Location: Thousand Oaks, CA
- Work Arrangement: Fully onsite