Cambridge, Massachusetts, United States · Hybrid
$143k–$176k/yr
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 e…
Skills: Clinical Trial Management, Vendor Oversight, Regulatory Compliance, SOP Management, ICH-GCP Guidelines
Cambridge, Massachusetts, United States · On-site
$107k–$139k/yr
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 e…
Skills: Quality Management Systems, CAPA, GMP, Documentation Management, Training Program Administration
Northwest Township, Indiana, United States · On-site
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 e…
Skills: Occupational Health And Safety, Regulatory Compliance, OSHA Compliance, Risk Assessment, Incident Investigation
Cambridge, Massachusetts, United States · On-site
$80k–$98k/yr
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 e…
Skills: Cell culture, Flow cytometry, ELISA, PCR, Molecular biology
Cambridge, Massachusetts, United States · Hybrid
$181k–$234k/yr
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 e…
Skills: U.S. GAAP, Financial Reporting, NetSuite, Technical Accounting, Audit Management
Cambridge, Massachusetts, United States · Hybrid
$120k–$154k/yr
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 e…
Skills: U.S. GAAP, Financial Close Process, NetSuite, Internal Controls, SOX Compliance
Cambridge, Massachusetts, United States · Hybrid
$175k–$226k/yr
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 e…
Skills: Clinical Trial Design, GCP Guidelines, Clinical Development Planning, Regulatory Submissions, Data Analysis
Northwest Township, Indiana, United States · On-site
$46k–$54k/yr
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 e…
Skills: Livestock Handling, Animal Research, Animal Welfare, Swine Operations, Microsoft Office Suite
Madison, Wisconsin, United States · On-site
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 e…
Skills: Environmental Monitoring, Microbiology Methods, Aseptic Technique, cGMP Compliance, Plate Enumeration
Northwest Township, Indiana, United States · On-site
$46k–$54k/yr
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 e…
Skills: Animal Handling, Veterinary Care, Infection Control, Clinical Observation, SOP Compliance
Madison, Wisconsin, United States · On-site
$46k–$54k/yr
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 e…
Skills: Animal Handling, Infection Control, Clinical Observation, Veterinary Procedures, SOP Compliance
Northwest Township, Indiana, United States · On-site
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 e…
Skills: Surgical Support, Anesthesia Monitoring, Inventory Management, GMP Compliance, Neonatal Monitoring
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The Senior Clinical Trial Manager will oversee day-to-day clinical study operations, including vendor management, site communication, and adherence to regulatory guidelines. They will also lead internal study teams and ensure all clinical documentation remains audit-ready and compliant with SOPs.
Candidates must possess a bachelor's degree in a life science field and at least 7 years of relevant work experience, including 4 years in biopharmaceutical clinical research. Proficiency in GCP guidelines and experience in managing external vendors like CROs are essential for this role.
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.
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.
\nPRIMARY RESPONSIBILITIESRestoring life after organ failure.
eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells. Harnessing the latest gene-editing techniques, eGenesis’ mission is to solve the global organ shortage crisis by developing a scalable alternative to allotransplantation. eGenesis is reinvigorating the field of xenotransplantation by addressing the key virology and immunology hurdles that have prevented its advancement to date, and is developing commercially-viable products to save and improve the lives of patients who are waiting for an organ transplant.
Offices: 300 Technology Sq, Cambridge, MA 02139, US
Restoring life after organ failure.
eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells. Harnessing the latest gene-editing techniques, eGenesis’ mission is to solve the global organ shortage crisis by developing a scalable alternative to allotransplantation. eGenesis is reinvigorating the field of xenotransplantation by addressing the key virology and immunology hurdles that have prevented its advancement to date, and is developing commercially-viable products to save and improve the lives of patients who are waiting for an organ transplant.
Offices: 300 Technology Sq, Cambridge, MA 02139, US
