Associate Director, Clinical Operations
Cambridge, MA
Clinical Development /
Full-Time /
Hybrid
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
eGenesis is seeking a resourceful and collaborative Associate Director 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 Associate Director, 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, CROs and vendors 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 set-up and management, CRO oversight, timelines, and budgets
- Lead site selection and site qualification discussions, kick-off meetings and study team meetings
- Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented
- Actively assess potential risks to the study and work closely with the cross-functional teams to mitigate downstream impacts
- Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Study Plans, 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, vendors 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
BASIC QUALIFICATIONS
- Bachelor’s degree
- 10+ years of work experience in life sciences or medically related field, including 7+ 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
- Life science or medical background preferred
- Previous CRA experience preferred
