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…
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$143k–$176k/yr
Full-time
bachelor degree
Posted 26d ago
~40 hrs/week
Responsibilities
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.
Requirements
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.
Full job description
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.
\nPRIMARY 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 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
How much do Management & Leadership jobs in Cambridge, MA pay?
Based on 941 listings with disclosed salaries, most management & leadership jobs in Cambridge, MA pay between $109k–$278k per year. Individual offers vary with seniority, company size, and specialization.
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There are currently 1,276 open management & leadership positions in Cambridge, MA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Cambridge, MA?
Companies currently hiring include Harvard Division of Medical Sciences, Sanofi, Biogen, Novartis, Takeda, among others. Browse the listings above to see every active employer.
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