Clinical Trial Manager

Climb Bio; Wellesley (MA); Hybrid; USD 132,000 - 175,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, Dental and Vision insurance

Stock options

401k company match

Generous paid time off

Job summary

Climb Bio is seeking a self-motivated Clinical Trial Manager to lead end-to-end delivery of clinical trials, with emphasis on Phase 1 execution and Phase 2 support. Reporting to the Director of Clinical Operations, this role supports regulatory submissions, TMF health, and trial budgeting from our Wellesley, MA area and offers remote or hybrid work options.

The ideal candidate has 3+ years managing trials across Phases 1–3, strong GCP knowledge, and excellent communication with external

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum of 3 years of experience independently managing clinical trials across Phases 1–3, including at least 2 years in a biotech setting.
• Working knowledge of GCP guidelines and regulatory requirements.
• Excellent communication and interpersonal skills with external partners.
• Proficiency in MS Office tools.

Responsibilities

• Serve as the Clinical Operations representative on study teams, leading study-level operational execution.
• Support and collaborate with Senior Clinical Trial Managers on complex studies.
• Accountable for end-to-end trial ownership, including study conduct, TMF health, documentation discipline, and regulatory submissions support.
• Operate effectively in a fast-paced biotech environment with quality and compliance.
• Partner with senior Clinical Operations leadership on study strategy and execution.

Skills

Clinical trial management

Communication skills

GCP knowledge

Interpersonal relations

Budget awareness

Education

Bachelor’s degree

Tools

MS Office

Job description

About Climb

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 development for IgA nephropathy.

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 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 lead end-to-end delivery of clinical trials, with immediate emphasis on owning Phase 1 execution and supporting Phase 2 execution. Reporting to the Director 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 study teams, leading study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC, and proactively driving alignment and issue resolution


• Support and collaborate closely with Senior Clinical Trial Managers on complex studies, operating in a support capacity while demonstrating eagerness to learn and grow into greater study ownership over time


• Accountable for end-to-end trial ownership, including clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply and regulatory submissions support, with responsibility for proactive study-level risk assessment, prioritization, and escalation


• Operate effectively in a fast‑moving biotech environment, demonstrating resilience, sound judgement under pressure, and the ability to adapt execution approaches while maintaining quality and compliance amid shifting priorities


• Partner with senior Clinical Operations leadership on study strategy and execution, issue solving, and development of high-quality, inspection‑ready operational approaches

Additional Responsibilities

• Support study startup and ongoing management in alignment with GCP, SOPs, and quality standards


• Serve as the study‑level operational lead during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAs


• Lead CRO and vendor execution with clear accountability for quality, timeline, and budget performance, exercising judgement to resolve issues, recommend trade-offs, and elevate risks as appropriate


• Support senior team members in tracking clinical expenses and budgets


• Prepare timely, accurate trial status reports for leadership

Qualifications

• Bachelor’s degree


• Minimum of 3 years of experience independently managing clinical trials across Phases 1 – 3, including at least 2 years in a biotech managing studies through start-up and maintenance stages


• Working 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 20%)

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, with ability to connect decisions to data integrity and compliance, and to influence and mentor others in quality behaviors

This role has the option of being remote or hybrid based out of our office in Wellesley, MA.

Base salary offered may vary depending on individual’s skills, experience, and competitive market value.

Salary Range: $132,000-$175,000

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.

Climb 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.