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Hemab Therapeutics · 21 hours ago

Senior Clinical Trial Manager

Cambridge, MA

Full-time

Onsite

Senior Level

5+ years exp

Hemab Therapeutics is a clinical-stage biotech company dedicated to addressing unmet needs in bleeding and thrombotic disorders. The Senior Clinical Trial Manager will play a crucial role in executing clinical trials, managing relationships with investigators, and overseeing all aspects of study operations.

BiotechnologyLife ScienceMedicalPharmaceutical

Responsibilities

Manage CRO study team(s), clinical sites, laboratory vendor(s), and other outsourced work on assigned studies to ensure consistency of methods, interpretation, and approach with other Hemab-sponsored studies

Lead global clinical trial execution across multiple regions and countries, ensuring coordination of multinational study teams and compliance with regional regulatory requirements

Lead in the development and review of protocols, study budgets, investigator brochures, clinical study reports, and other clinical documents and regulatory filings as needed

Implement study startup activities, including the development of informed consent forms, study training materials, manuals, plans, and study tools for assigned study

Oversee regulatory/ethics submissions

Effectively evaluating qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed

Oversee day to day study conduct; including management of operation questions from CRO and sites, tracking subject recruitment, laboratory samples, and review of monitoring reports; responsible for study close-out activities

Assess study drug requirements and shipment and supply logistics, contributing to pharmacy manual

Manage study timeline and provide study progress reports to management

Maintain tracking for study metrics that are essential to managing the study closely (patient visit information, data entry, monitoring, and data cleaning information, etc.)

Oversee TMF filing and QC activities as needed

Ensure that all tasks that contribute to the conduct of a clinical study are completed according to ICH/GCP and SOPs, as well as on time and within budget

Train and mentor junior team members

Qualification

Clinical trial managementGlobal clinical trialsICH/GCP regulationsPhase 3 trialsRare disease experienceTask prioritizationCommunication skillsTeam mentoring

Required

Bachelor's Degree in life sciences or healthcare discipline

At least 5-7 years of clinical trial management experience and at least 2 years of clinical monitoring experience in the biotech/pharmaceutical industry

Proven experience managing Phase 3 clinical trials from initiation through completion

Direct experience conducting global/multinational clinical trials across multiple geographic regions (US, EU, MENA, Asia-Pacific preferred)

Experience in rare disease or orphan drug development, with demonstrated understanding of unique challenges in patient recruitment, regulatory pathways, and engagement with specialized centers

Working knowledge of ICH/GCP regulations and guidelines

Solid understanding of cross-functional areas, including data management/biostatistics, regulatory affairs, and pharmacovigilance

Proven verbal and written communication skills; enjoys interacting with others regularly

Able to prioritize tasks and work independently

Able to travel an average of 20-30%, both domestically and internationally