Senior Clinical Trial Manager

Senior Clinical Trial ManagereGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company's proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. eGenesis is headquartered in Cambridge, MA.POSITION SUMMARYeGenesis 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 RESPONSIBILITIESAssist in overall management of clinical trials, including managing study timelines and budgets as well as providing CRO and other external vendor oversightAssist in preparation and review of clinical study documentation including protocol, informed consent, study plans, lab manuals, 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 a point of contact for CRO and clinical site communicationAssist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic reviewsLead internal study team calls and ensure appropriate cross functional follow up and resolution to tasks in a timely mannerParticipate 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 impactsQUALIFICATIONSBachelor'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 $142,800 - $176,400.