Clinical Research Manager (CRM)

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic.

Summary

Fortvita is seeking a dynamic and experienced Clinical Research Manager (CRM) to lead the planning, execution, and delivery of Phase 1-3 clinical trials. This role will oversee day-to-day trial operations and cross-functional coordination, ensuring our clinical programs are executed with excellence, delivered on time, and in full compliance with GCP and regulatory standards. The ideal candidate will possess a strong background in clinical trial site management , Oncology drug development, and be able to collaborate with internal and external stakeholders to advance high-quality trials that support Fortvita’s mission. This role requires working hybrid or remote.

Responsibilities

• Team Leadership: Manage, mentor, and support a team of 8 CRAs; provide ongoing coaching, performance management, and professional development.
• Trial Oversight: Oversee the execution of the Phase 3 clinical study, ensuring adherence to protocol, timelines, GCP, FDA regulations, and company SOPs.
• Site Management: Guide the CRA team in site selection, initiation, monitoring, and closeout visits to ensure high-quality data collection and compliance.
• Risk Mitigation: Identify operational risks early and implement mitigation strategies to resolve site and study-level challenges.
• Quality Assurance: Ensure data integrity, patient safety, and regulatory compliance throughout the study lifecycle.
• Collaboration: Serve as the primary point of contact between CRAs, clinical project management, medical monitors, vendors, and investigational sites.
• Reporting: Prepare and present study progress reports, metrics, and issue logs to upper management and cross-functional teams.
• Inspection Readiness: Maintain documentation and processes to ensure the study is always inspection-ready.

Qualifications

Required

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum of 10 years of clinical research experience, including at least 5 years in clinical trial management or team leadership roles.
• Strong working Knowledge of FDA and ICH-GCP regulatory requirements.
• Proven ability to manage a team of CRAs.
• Proficient in CTMS, eTMF, and EDC systems.
• Excellent communication, proven leadership, organizational, and interpersonal skills.
• Excellent written and verbal communication; ability to present complex information clearly.
• Willingness to travel as required (up to 40%).

Preferred

• Oncology trial experience is highly preferred.
• Prior experience working in global studies or multiple site operations.
• Ability to motivate teams and foster collaboration.
• Detail-oriented with strong problem-solving skills.
• Experience working in a fast-paced or startup environment.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.