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eGenesis
Cambridge, MA
Source: eGenesis careers · View original posting
From eGenesis's posting. “We” and “our” refer to the employer.
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
Base pay range for this job is $142,800 - $176,400.
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