Senior Clinical Trial Manager

Lexeo Therapeutics•New York, NY

4d•$150,000 - $175,000•Hybrid

About The Position

The Senior Clinical Trial Manager (Sr. CTM), in collaboration with the clinical operations program leader, will define the clinical operations strategy and be responsible for country and global execution of complex clinical trials end-to-end consistent with the clinical plan. The Sr. CTM will be responsible for partnering with internal and external business functions and vendors throughout the life cycle of one or more clinical study(ies) in accordance with company SOPs, ICH/GCP, and all applicable local regulations. Candidates for this role must champion a culture of quality and continuous process improvement.

Requirements

BA/BS degree with 5 plus years clinical trial management experience and/or an advanced degree (MS/PhD, PharmD) with at least 2 years of study management experience. Biotech experience preferred and a degree in life sciences or equivalent
Strong knowledge of ICH/GCP/FDA regulations site monitoring/CRA experience is required
Proven clinical study management skills, and experience of the operational aspects of all stages of clinical studies, including the development of timelines and budgets. Preferably working in a global environment, working with vendors and/or CROs, drug supply management and planning operational activities
Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction
Excellent written and verbal communications skills
Analytical and problem-solving capabilities
Collaborative and collegial work style
Attention to detail and follow-up
Ability to travel to domestic and/or international sites as needed
Ability to travel quarterly to New York City HQ

Responsibilities

Manage and lead the day-to-day operations of assigned study (ies) to ensure completion per established program goals
Manage and lead cross-functional teams (pre-clinical development, clinical pharmacology, safety, regulatory affairs, clinical supply, biometrics, legal, and medical affairs) and ensure vendors (e.g., CROs, labs, etc,) are compliant with contracted scope of work
Support the establishment of the clinical trial budget and coordinate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget
Perform ongoing vendor management and oversight during the study, including review of performed work against budget, negotiation of scope of work, budget amendments, performance management and issue resolution in close collaboration with the Head of Clinical Operations and Project and Portfolio organization
Ensure rigor and availability of documentation to demonstrate sufficiency of sponsor oversight
Review and contribute to operational plans including risk-based approaches to site monitoring, fit for purpose strategies for patient recruitment and retention, patient diversification targets, vendor and site reporting requirements, risk identification and mitigation strategies, trial budgets, site selection, and clinical supplies management
Provide operational input for operational risk assessments, including patient and site burden, diversity considerations during the protocol development process and database design
Contribute to the initial development of the study timelines, deployment of allocated resources, budget, risk and quality plans, escalate issues that may jeopardize time, cost, and the quality of study deliverables
Lead the preparation of vendor requirements, including the definition of project scope, confirmation of vendor qualification and subsequent selection of key partners. Be responsible for the study team health, including collaborative partners. Oversee feasibility assessments with input from Clinical Development Lead and other relevant cross-functional partners towards the optimal selection of countries and clinical sites
Ensure inspection readiness at all times
Author, audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (pharmacy, laboratory, and operations manuals/plans) are sufficiently clear and available for study initiation and execution
Work closely with study sites/vendors to ensure timely and appropriate processes for obtaining, and shipping of sample viability for analysis and data generation
Monitor and communicate with the CRO to ensure data currency i.e., cleaned and coded appropriately to meet all program milestones
Ensure appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from audits and inspections
If required coordinate/provide input to Regulatory Affairs for responses to study questions or issues from Health Authorities
Coordinate responses to study related questions or issues from IRBs/IECs
Accountable for the overall integrity of the TMF for each respective trial
Ensure study adherence to ICH/GCP/FDA regulations and SOPs
Function as a lead on LEXEOâs Clinical Operation initiatives
Other clinical operation activities that are delegated by Clinical Operations Leadership