Senior Clinical Trial Manager (23002-B-615-MED)
South San Francisco /
Medical Sciences /
ArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Sr. Clinical Trial Manager to work remote based in our South San Francisco office.
ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer, and prioritize the team’s outcomes over individual goals to achieve our company mission – together.
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Sr. Clinical Trials Manager will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of 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 have partnerships that include both internal and external stakeholders.
What You Will 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/or 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 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, 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 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.
What Will You Bring:
- Your whole self
- BS/BA in nursing, science or health-related field with 5+ years experience of related oncology clinical trial management experience, OR
- MS/MA in nursing, science or health-related field with 3+ years experience of related oncology clinical trial management experience
- Experience managing complex early phase clinical trials in cell therapy or immuno-oncology
- Competent knowledge of transplant patient care and apheresis collection is a plus.
- Clinical research knowledge and cross-functional understanding of the clinical trial methodology
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
- Developed leadership skills to successfully lead a clinical study team
- Willing to travel to clinical sites as needed
- Ability to deal with time demands, incomplete information, or unexpected events
- Must display strong analytical and problem-solving skills
- Attention to detail required
- Outstanding organizational skills with the ability to multitask and prioritize
- Excellent interpersonal, verbal, and written communication skills are essential to working in a matrix team
- Creative and innovative mindset to approach novel problem statements
- Willingness to learn and adapt to new technologies
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
What We Will Offer You:
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $144,700–$177,200.
Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.