Senior Clinical Trial Manager

Cambridge, MA - USA

Monthly Salary: $ 134400 - 201600

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Bachelors 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 $134400 - $201600.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Manager

COMPANY MISSIONeGenesis 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 Clin...