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Senior Manager, Clinical Data Management (24209-U-615-MED)
ArsenalBioSouth San Francisco, United Statesfull_timeVerifiedPosted 29 Aug 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 and experienced Senior Manager, Clinical Data Management to work remote based in our South San Francisco Office 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.
Step into the spotlight as the Lead Clinical Data Manager (CDM) for groundbreaking clinical trials! In this dynamic role, you'll be at the forefront of ensuring the delivery of top-tier data management results that drive the success of our clinical research. You'll provide instrumental direction in overseeing CROs and ensuring every clinical data management milestone is met precisely and efficiently. As a critical point of contact across one or more high-impact clinical trials, your expertise will be pivotal in shaping the future of healthcare.
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.
Step into the spotlight as the Lead Clinical Data Manager (CDM) for groundbreaking clinical trials! In this dynamic role, you'll be at the forefront of ensuring the delivery of top-tier data management results that drive the success of our clinical research. You'll provide instrumental direction in overseeing CROs and ensuring every clinical data management milestone is met precisely and efficiently. As a critical point of contact across one or more high-impact clinical trials, your expertise will be pivotal in shaping the future of healthcare.
WHAT YOU’LL DO
- Provide oversight of data management activities from start to finish (e.g., EDC build, UAT, developing CDM-related plans, data reviews, database lock)
- Lead CDM partnership with CROs and provide oversight/management to ensure timely deliverables are met. Identify any data gaps, issues or risks and implement solutions or mitigation plans
- Author and review all clinical data management-related study plans/documents (e.g., CRF Completion Guidelines, Data Management Plan, Data Review Plan, SAE Reconciliation Plan, Coding Conventions, Local Lab Conventions)
- Work with internal and external study teams to plan, coordinate, and deliver complete and high-quality data for milestone deliverables
- Coordinate with cross-functional teams (e.g., clinical operation, medical monitor, biostatistics, statistical programmer) for CRF/EDC database designs and data collection to meet protocol requirements for BLA submission. Establish data listings/review tools for ongoing data reviews
- Collaborate with the translational science team and third-party vendors to develop Data Transfer Specifications and manage data reconciliation
- Work collaboratively with cross-functional teams to set up other data collection systems (e.g., ePRO, central imaging, IWRS/IVRS, safety database) and provide input on data collection, reporting requirements, and data transfers
- Participate in strategy planning to support program deliverables and corporate goals
- Attend internal and external meetings as the lead data manager representative and provide ongoing study data metrics and DM-related updates
- Participate in CROs and vendor selections for outsourced activities across assigned projects. Support budget and resource planning across assigned projects. Review and approve DM CRO/vendor invoices against the study contracts
- Review and contribute to DM SOPs and working documents related to DM activities
- Manage and provide training to junior data managers, if applicable
- May assist with BLA readiness planning and audit inspection activities, if applicable
- File and review data management documents in the electronic Trial Master File (eTMF)
WHO YOU ARE
- BS/BA with a minimum of 10+ years of data management experience in the biotechnology or pharmaceutical industry or MA/MS with 8+ years
- Relevant CRO oversight experience with at least four years of data management oversight experience
- Proven experience with leading clinical study trials with the ability to manage multiple successful study deliverables from start to finish
- Able to work with minimal guidance and collaborate with cross-functional groups on multiple projects
- Ability to multi-task and shift priorities while working under tight timelines
- Familiar with the implementation of Good Clinical Practice (GCP) as it applies to clinical data management
- Strong verbal and written communication skills, allowing for open and effective dialogue throughout the company and with business partners
- In-depth knowledge and experience with Medidata Rave system Preferred Qualifications
- Experience with clinical trials in oncology, preferred cell therapy
- Knowledge of
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