Senior Clinical Trial Management Associate (24006-B-615-MED)
South San Francisco
Medical Sciences /
Full-Time /
Hybrid
WHO WE ARE
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely 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.
Join us in making a significant impact! Clinical Operations is the driving force behind our clinical trial excellence, working closely with Technical Operations to ensure high-quality, timely drug delivery and shaping the future of medicine. We seek a passionate, experienced Senior Clinical Trial Management Associate. This role offers the opportunity to thrive in a fast-paced, high-energy environment with both internal teams and external partners, bringing transformative treatments to patients. We want to hear from you if you’re ready to lead the charge and make a real difference!
WHAT YOU’LL DO
- Assist in all operational aspects of the assigned clinical trial(s) and support the clinical trial(s) conduct including vendor selection process, study start-up, enrollment, study conduct, and close-out
- Assist in review of study-related and essential clinical study start-up documents (e.g., Clinical protocols, regulatory document packages, 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).
- Assists in training and managing CRO and vendors such as Central lab, Imaging, etc
- Assists in data review and/or data metric review in preparation for data cuts
- May be responsible for apheresis planning to support enrollment of study participants and liaise with investigative sites and supply chain to support activities involved in the cell journey
- May 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
- Responsible for biospecimen sample routing, tracking, and query resolutions between clinical sites and the central lab and CROs.
- Responsible for planning, coordinating, and tracking biospecimen shipments (PK, biomarkers) between central lab and specialty vendors
- Assists with the review of IRB/EC documents in coordination with CRO, as appropriate
- Assists in site selection and the start-up processes toward activating sites
- Responsible for filing necessary documents in the electronic trial master file (eTMF), and for leading regular cross-functional reviews of the eTMF.
- Maintain tracking of various study activities to assist the study lead with required updates required for senior leadership
- Assist in CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring report review, site management, TMF, EDC, etc).
- Develops relationships with investigators and site staff as well as serve as a liaison and resource for investigational sites.
- Under supervision, participate in the development, review and implementation of departmental SOPs and processes.
- Support other studies as required and other duties as assigned
WHO YOU ARE
- BS/BA in nursing, science or health-related field with 4+ years experience of related oncology clinical trial management experience
- Experience with vendor management & CRO oversight preferred
- Competent knowledge of transplant patient care and apheresis collection is a plus
- Clinical research knowledge and cross-functional understanding of the clinical trial methodology
- 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 multi-task 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
BENEFITS AND PAY
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.
Our people-first culture cultivates a deep respect for humanity, not only in those we serve but also in one another. We take pride in being part of a company that values and celebrates diversity—in experiences, ideas, and interests. We are empowered in an environment that embraces unity and inclusivity, fostering a sense of belonging and mutual respect.
We provide powerful tools to empower our employees to take charge of their career paths and reach their full potential. At ArsenalBio, we believe in investing in our employees' well-being—both professionally and personally—because our people are our most valuable asset. Our essential team members bring exceptional expertise in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software, and other fields to turn the possibilities of tomorrow into the realities of today.
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 deeply value diversity within our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.
The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $110,200–$135,000. Salary ranges for other locations may vary. Base pay offered may vary based on job-related knowledge, experience, education, and location. Beyond these considerations, we are committed to pay equity and consider the internal equity of our current employees when making any final offers.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias or to ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.
