Manage day-to-day clinical trial operations, vendors, and sites; maintain TMF and study documentation; ensure compliance with SOPs and ICH-GCP; lead cross-functional study communications, timelines, and risk mitigation; coordinate audits and resolve findings.
About eGenesis
eGenesis 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. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
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
- Assist in overall management of clinical trials, including but not limited to managing study timelines and budgets as well as providing CRO and other external vendor oversight
- Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, study plans, lab manuals, Case Report Forms, Clinical Study Reports, and other study level documents
- Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
- Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
- Serve as a point of contact for CRO and clinical site communication
- Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic reviews
- Lead internal study team calls and ensure appropriate cross functional follow up and resolution to tasks in a timely manner
- Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
- Proactively 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 preferred
- 7+ 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 company
- Experience 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 organization
- Working knowledge of Good Clinical Practices (GCP) and other relevant regulatory requirements
- Ability to travel up to 10% of the time
- Ability to be onsite in the Cambridge office 2 days per week
Base pay range for this job is $142,800 - $176,400.
eGenesis Boston, Massachusetts, USA Office
Boston, MA, United States
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