Lead day-to-day management of clinical studies, vendors, CROs, timelines, and budgets. Prepare and review study documents, maintain trial master file, ensure GCP/SOP compliance, coordinate audits, communicate status to stakeholders, and identify/mitigate study risks.
COMPANY MISSION
eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.
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
- Manage all aspects of clinical trials, including study vendor management, CRO oversight, timelines, and budgets
- Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, 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 point of contact for CRO and clinical site communication
- Set up the Trial Master File (TMF) and appropriately maintain the TMF throughout the trial, including periodic reviews
- 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 $134,400 - $201,600.
eGenesis Cambridge, Massachusetts, USA Office
300 Technology Sq, Cambridge, MA, United States, 02139
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