Jobs and Careers

Senior Clinical Trial Manager (24124-R-615-MED)

South San Francisco, United Statesfull_timeVerifiedPosted 8 Oct 2024

💰 $180,000/yr($146,900/yr – $180,000/yr)

About the role

WHO WE AREArsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented Senior Clinical Trial Manager to work hybrid based in our South San Francisco office.
ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines as well as clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM advancing therapies for patients who need it most.
Get ready to make a major impact! Clinical Operations is the heartbeat of our clinical trial excellence, driving the future of medicine hand in hand with Technical Operations to guarantee top-tier drug quality and timely delivery. We are seeking a dynamic, passionate and experienced Senior Clinical Trial Manager. The Sr. Clinical Trial Manager will support all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must know clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. This role will require an ability to operate in a fast-paced, highly dynamic environment within a matrix team and partner with internal and external stakeholders. This is your chance to thrive in a fast-paced, high-energy environment, collaborating with both internal teams and external partners to bring transformative treatments to patients. If you’re ready to lead the charge and make a real difference, this is your opportunity!

WHAT YOU’LL DO

Manage all operational aspects of the assigned clinical trial(s) and manage the clinical trial(s) conduct including vendor selection process, study start-up, enrollment, study conduct, and close-out
Create, plan, and review study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, CTA/Budget, Investigational Product Manual, Monitoring Plan, Laboratory Manual, Case Report Form (CRFs), CRF Completion Guidelines, training documentation/tools, and other relevant study plans and charters).
Manage and oversee study submissions to IRB/ECs in coordination with CRO, as appropriate
Work with the CRO to select and approve sites and manage the start-up processes toward activating sites
Oversee, manage and/or support apheresis planning to support enrollment of study participants and liaise with investigative sites and supply chain to support activities involved in the cell journey
Oversee and/or coordinate with the supply chain on all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sites
Manage and update key metrics and dashboards required for senior leadership
Interface with cross-functional teams as Clinical Operations study lead (e.g. Medical Monitor, Regulatory Affairs, IT, CMC/Supply Chain, Translational, CRO, vendors and Investigators/site staff).
Provide study-related guidance and leadership to internal and external partners, as appropriate.
Drive and manage data review in preparation for data cuts
Support enrollment forecasting and budget review and approval and review study-related invoices
Provide training and manage CRO and vendors such as Central lab, Imaging, etc including the management of study-specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.
Further manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, TMF, EDC, etc). Create and implement a corrective action plan when performance expectations are not being met.
Proactively identify, manage, and track potential study issues/risks and recommend/implement solutions.
Develop relationships with investigators and site staff as well as serve as a liaison and resource for investigational sites.
Participate in the development, review and implementation of departmental SOPs and processes.
Support other studies as required
Other duties as assigned.