Clinical Trial Manager

Clinical Trial ManagerClimb 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 resolutionSupport 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 timeAccountable 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 escalationOperate 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 prioritiesPartner with senior Clinical Operations leadership on study strategy and execution, issue solving, and development of high-quality, inspection?ready operational approachesAdditional Responsibilities:Support study startup and ongoing management in alignment with GCP, SOPs, and quality standardsServe as the study?level operational lead during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAsLead CRO and vendor execution with clear accountability for quality, timeline, and budget performance, exercising judgement to resolve issues, recommend trade-offs, and escalate risks as appropriateSupport senior team members in tracking clinical expenses and budgetsPrepare timely, accurate trial status reports for leadershipQualifications:Bachelor's degreeMinimum 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 stagesWorking knowledge of clinical research processes, GCP guidelines, and regulatory requirementsExcellent communication and interpersonal skills with a focus on managing external relationships effectivelyProficiency in MS SuiteAbility to travel occasionally (approximately 20%)Key Competencies:Strategic planning and organizational skillsAnalytical and problem-solving abilitiesAbility to work effectively with external partners in a dynamic, fast-paced environmentAttention to detail and commitment to quality, with ability to connect decisions to data integrity and compliance, and to influence and mentor others in quality behaviorsThis 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-$175,000Additional 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.