Arsenal Bio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Sr. Clinical Trial Management Associate (Sr. CTMA) to work remotely.
ArsenalBioâs mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. 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 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: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-outAssist 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 cutsMay 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 journeyMay coordinate with supply chain on all aspects of study participant sample collection and âcell journeyâ including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sitesResponsible 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 vendorsAssists with the review of IRB/EC documents in coordination with CRO, as appropriateAssists 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 eTMF.Maintain tracking of various study activities to assist the study lead with required updates required for senior leadershipAssist 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
What Will You Bring:Your whole selfBS/BA in nursing, science or health-related field with 4+ years experience of related oncology clinical trial management experienceExperience with vendor management & CRO oversight preferredCompetent knowledge of transplant patient care and apheresis collection is a plusClinical research knowledge and cross-functional understanding of the clinical trial methodologyWilling to travel to clinical sites as needed Ability to deal with time demands, incomplete information, or unexpected eventsMust display strong analytical and problem-solving skillsAttention to detail requiredOutstanding organizational skills with the ability to multi-task and prioritizeExcellent interpersonal, verbal, and written communication skills are essential to working in a matrix teamCreative 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
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 âArsenal Days of Restâ 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.
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 $110,200 â $135,000. 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.
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