COMPANY MISSION
eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.
eGenesis is seeking a resourceful and collaborative Senior Clinical Trial Manager to join our Clinical
Operations team to support programs across our portfolio. This role will work closely with our teams
across Regulatory, Quality, GMP Production, and Development to successfully drive our clinical
programs. As the Senior Clinical Trial Manager, you will be responsible for the day-to-day management
of our clinical studies, vendors, and sites in alignment with corporate and program goals. You will work
closely with clinical sites and CROs to ensure compliance with SOPs and regulatory guidelines. To be
successful in this role, you will leverage a passion for the details, excellent communication skills and an
eagerness to collaborate.
PRIMARY RESPONSIBILITIES
Manage all aspects of clinical trials, including study vendor management, CRO oversight, timelines, and budgetsAssist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documentsEngage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelinesEnsure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelinesServe as point of contact for CRO and clinical site communicationSet up the Trial Master File (TMF) and appropriately maintain the TMF throughout the trial, including periodic reviewsParticipate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical filesProactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts
QUALIFICATIONS
Bachelor’s degree, life science or medical background preferred7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO companyExperience in oversight of external vendors (e.g. CROs, central labs, etc.)Strong interpersonal and organizational skills are needed, with a high degree of attention to detail with ability to flex communication style to all areas of the organizationWorking knowledge of Good Clinical Practices (GCP) and other relevant regulatory requirementsAbility to travel up to 10% of the timeAbility to be onsite in the Cambridge office 2 days per weekBase pay range for this job is $134,400 - $201,600.
