This is an exciting opportunity to work within a fast-paced environment with a dedicated, and passionate team. As a Sr. CRA/CTM, you will be responsible and accountable for managing operational activities for assigned early phase studies and vendor management. The Sr. CRA/CTM provides operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. The Sr. CRA/CTM will partner with key stakeholders (internal and external) to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment. This role is on-site in Redwood City, CA.

Essential Responsibilities:

• Responsible for overseeing all facets of early phase clinical trials, from CRO selection, initial startup phase through data base lock in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs).
• Responsible for milestone tracking, timeline and budget management.
• Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance.
• Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense).
• Manage vendor operational meetings to ensure project goals and timelines are met.
• Assist with or be responsible for the management of key study parameters (e.g., start-up activities, site feasibility, enrollment, site management, data collection, data review, database lock, etc.).
• Participate in the development and review of study materials, including but not limited to informed consent forms, case report forms, and study manuals.
• Proactively identify and assist with the analysis and development of action plans to address issues with investigational sites and/or vendors.
• Review/approve invoices and ensure timely payment processing for vendors.
• Ensure Trial Master File is maintained throughout the study, is inspection-ready for all assigned studies.
• Assist with the planning, coordination, and presentation at SIVs, and ad hoc trainings, as requested.
• Develops, distributes, reviews and track essential trial documents.
• Provide Regulatory with Site Essential Regulatory Documents for submission to the FDA.
• Develop and ensure compliance with study plans and provide monitoring oversight.
• Maintain study trackers.

Education and Experience Requirements:

Education/Experience:

• BA/BS required, preferable in a scientific/medical field. Advanced degree preferred.
• 5-7 years of experience in Clinical Operations, working with CROs and other vendors, with increasing responsibility and scope.
• Early phase and start up experience required. Must have experience in early development (Clinical Pharmacology studies e.g. DDI; FE; BA/BE, special populations, and others).
• Experience working with Phase 1 units.
• Working knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
• Experience working in cross-functional environment.
• Demonstrated experience in selecting, managing, overseeing, and successfully developing effective relationships with internal and external stakeholders.
• Proficiency with Microsoft applications
• Prior experience working in a start-up environment is a highly desired.
• Strong Project Management skills

Specific Qualifications Include:

• Highly motivated and enjoys working in a fast-paced, dynamic environment.
• Strong organizational skills and ability to prioritize and multi-task.
• Positive, flexible, self-starter, and thrives under pressure.
• Excellent judgment and problem-solving skills.
• Exceptional verbal and written communication skills.
• Flexible related to responsibilities/assignments.
• Willingness to travel as necessary, consistent with project needs.
• Ability to work cross-functionally at all levels within Biomea Fusion and externally.

Industry:

• Biotechnology

Employment Type:

• FTE

Equal Employment Opportunity:At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

The expected salary range for this role is $130,000 to $170,000 depending on the level. An individual’s position within the range may be influenced by multiple factors, including education, years of relevant industry experience, and market dynamics. These factors will determine the actual salary offered. Base salary is one part of the overall total rewards program, which includes competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.