The Senior Study Manager will manage the outsourcing operations for Nonclinical Development studies to CRO sites enabling the transition of a R&D project from entry into development up to and beyond NDA/BLA submission. Outsourcing management includes business relevant processes from the CRO sourcing to study reporting like requesting quotes, launching purchase orders, engaging with procurement and legal as required. In close collaboration with Beam team members and internal stakeholders, the Nonclinical Development Senior Study Manager oversees the initiation, progression, and quality of operations at the vendor under adherence to scientific project team objectives, strategy, and timelines.
- Point of contact for study communications, activities, and documents from pre-study to study closure (finalization and archiving).
- Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan.
- Support vendor quality oversight in partnership with Nonclinical leadership, Nonclinical Development Operations and Quality Operations.
- Manage, communicate, and ensure adhesion to study timelines and milestones.
- In partnership with the Beam scientists, contribute to the study design, and regulatory submissions (as applicable).
- Work collaboratively with internal and external cross-functional teams or stakeholders.
- Preparation, review, and finalization of nonclinical study documents including protocols, amendments and reports.
- Participate in CRO vendor selection/ due diligence activities.
- Assist in supplier cost and performance at the study level with attention toward opportunities for cost efficiencies.
- Responsible for working with CROs to request slot availability and request quotes for the planned nonclinical studies.
- Communicate and manage study changes and issues; know when and how to escalate issues to management for resolution.
- Monitor the performance of nonclinical studies onsite or remotely at Contract Research Organizations.
- Maintain collaborative relationships and communications between external service providers.
- Ensure compliance with study protocols, GLP regulations (as applicable), and department work instructions.
- Coordinate study samples receiving and archiving.
- Bachelor’s degree in a scientific-related field with a minimum 10 years of experience in the pharmaceutical, biotechnology, CRO industry.
- Familiarity and working knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology).
- Familiarity with GLP regulations for the conduct of nonclinical studies to support regulatory filings.
- Demonstrated a team player attitude, ability to work independently in a fast paced, dynamic, and changing environment, takes initiative to identify, analyze and resolve issues.
- Ability to travel to CRO to monitor outsourced studies.
- Experience in working with CROs.
- Excellent communication and presentation skills.