Senior Clinical Trial Management Associate (24123-R-615-Med)

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 Senior Clinical Trial Management Associate to work onsite/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 Management Associate.  The Sr. Clinical Trials Management Associate 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 have partnerships that include both 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!

\n WHAT YOU'LL DOAssist in all operational aspects of assigned clinical trials, including supporting the full trial process from vendor selection and study start-up through enrollment, ongoing study conduct, and close-outAssist in reviewing 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) 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 journeyCoordinate 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 sitesCollaborate with translational operations on biospecimen sample routing, tracking, and query resolutions between clinical sites and the central lab and CROs.Assist with the review of IRB/EC documents in coordination with CRO, as appropriateAssist in site selection and the start-up processes toward activating sitesResponsible for filing necessary documents in the electronic trial master file (eTMF), and for leading regular cross-functional reviews of the eTMFMaintain tracking of various study activities to assist the study lead with required updates required for senior leadershipAssist in data review and/or data metric review in preparation for data cutsAssist in training and managing CRO and vendors such as Central lab, Imaging, etc Assist in CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring report review, site management, TMF, EDC, etc) Develop productive relationships with investigators and site staff as well as serve as a liaison and resource for investigational sitesParticipate in the development, review, and implementation of departmental SOPs and processes with supervisionSupport other studies as requiredOther duties as assigned WHO YOU AREBS/BA in nursing, science or health-related field with 4+ years experience of related oncology clinical trial management experienceCompetent knowledge of transplant patient care and apheresis collection is a plus.Clinical research knowledge and cross-functional understanding of the clinical trial methodologyWilling to travel to clinical sites as needed Ability to productively and successfully deal with time demands, incomplete information, or unexpected eventsMust display strong analytical and problem-solving skillsOutstanding attention to detail and organizational skills with the ability to multi-task and prioritizeDemonstrated excellence in interpersonal, verbal, and written communication skills, with the ability to collaborate effectively within a matrix team environmentCreative and innovative mindset to approach novel problem statements Willingness to learn and adapt to new technologiesComfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
\nBENEFITS 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 fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity. We have robust 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 our people 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. 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 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.  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. Candidate Privacy Policy