Clinical Trial Manager
About Climb Bio:
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include, budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.
At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We are seeking a self-motivated Clinical Trial Manager to oversee and coordinate all aspects of clinical studies from startup to close out. Reporting to the VP of Clinical Operations this person will play a critical role in enabling Climb to deliver on its mission.
Key Responsibilities:
- Serve as the Clinical Operations representative on project teams, with support from senior team members as needed
- Apply clinical development and operational expertise to ensure the successful execution of clinical studies
- Oversee clinical studies to ensure compliance with corporate and regulatory standards
Additional Responsibilities:
- Act as the lead Clinical Operations representative on project teams, collaborating with senior team members as required
- Coordinate and manage Clinical Team meetings to support project objectives
- Assist senior Clinical Operations team members with the setup and management of clinical studies, ensuring adherence to regulatory and quality standards, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs)
- Provide oversight of clinical conduct, drug supply, regulatory submissions, data management, and finalization of clinical study reports.
- Collaborate with key stakeholders at Contract Research Organizations (CROs) to manage delegated responsibilities, including clinical execution, drug supply, regulatory compliance, and data management
- Support senior team members in tracking clinical expenses and budgets
- Maintain and manage clinical trial documentation, ensuring proper filing and organization
- Review and provide input on study-related documents generated by CROs
- Prepare and deliver accurate, timely reports on clinical trial status for senior leadership (monthly, quarterly, or as needed)
- Partner with the Climb Bio Quality Team to ensure compliance with SOPs
Qualifications:
- Bachelor’s degree
- Proven experience in managing clinical trials, ideally with a minimum 5 years’ experience across all phases of clinical research
- At least 2 years of experience in a small biotech or clinical research organization
- In-depth knowledge of clinical research processes, GCP guidelines, and regulatory requirements
- Excellent communication and interpersonal skills with a focus on managing external relationships effectively
- Proficiency in MS Suite
- Ability to travel occasionally (approximately 15%)
Key Competencies:
- Strategic planning and organizational skills
- Analytical and problem-solving abilities
- Ability to work effectively with external partners in a dynamic, fast-paced environment
- Attention to detail and commitment to quality
This role has the option of being remote or based out of our office in Wellesley, MA.
Base salary offered may vary depending on individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.
Qualified candidates are encouraged to forward their resumes to [email protected]
Climb Bio is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.