Senior Manager, Clinical Data Management

Senior Manager, Clinical Data ManagementBurlington, MAWorking with UsMBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides.Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential.Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform.If you're passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team.What You'll DoThe Senior Manager, Clinical Data Management (CDM), reporting to Director, Clinical Data Strategy and Management, will play a pivotal role in a dynamic, cross-functional clinical development team focused on advancing treatments for endocrine and metabolic disorders. This role will provide hands-on leadership on day-to-day data management activities across MBX portfolio to ensure high quality and inspection ready clinical databases and data from all sources, while serving as a key data management partner to Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Safety, Quality, Medical Writing, and external data vendors.Lead day-to-day clinical data management operations across MBX programs.Provide oversight of EDC and eDiary/eCOA design, development, and ongoing database modifications, including review and approval of specifications. Ensure core team's input is incorporated for robust design.Oversee and perform User Acceptance Testing (UAT), validation activities, and documentation to ensure compliant, high-quality databases.Develop, maintain, and update Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), and related DM documentation.Lead data review meetings, including delivery of data listings to clinical and medical teams.Lead proactive data surveillance and critical data reviews/reconciliations to ensure data completeness, quality, and timely availability of primary and key secondary endpoint data.Oversee CRO data management teams and all external data vendors, including execution of Data Transfer Agreements and oversight of timely data transfers (and quality).Oversee integration and reconciliation of external data sources, including IRT, eCOA/eDiary, central laboratory, specialty laboratory, imaging, and safety data.Lead database interim and final lock planning and execution, including timeline development, risk tracking, and on-time data delivery to Biostatistics.Oversee final subject data profile generation format review and deliveries to the sites.Ensure TMF data management documentation quality and QC, including timely filing, completeness, and inspection readiness.Ensure all data management activities and documents are in inspection ready state.What You'll BringMaster's degree in Life Sciences, Health Sciences, Data Management, Computer Science, or a related field; advanced degree is a plus.Experience with Medidata Rave or equivalent EDC systems. Demonstrated hands-on experience with EDC design, database development, specifications review, UAT oversight, ongoing database modifications, and lock.Experience with eCOA/eDiary systems, including design review, specifications review, UAT oversight, ongoing database modifications and vendor management.Experience with data from multiple sources including, but not limited to central laboratory, IRT, specialty labs, etc.Ability to lead proactive data surveillance and critical data review to ensure completeness and integrity of primary and key secondary endpoint data and support timely study decision-making.9+ years of experience in Clinical Data Management within biotech, pharmaceutical, and/or CRO environments. Demonstrate experience serving as Lead Data Manager on global Phase 2 and Phase 3 clinical studies.Strong experience authoring and maintaining Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), Data Transfer Agreement (DTA), Data Oversight Plan (DOP), and other DM documentation.Proven ability to oversee CRO data management teams and external data vendor partners.Experience supporting database lock planning and execution, including delivery to Biostatistics.Solid knowledge of ICH-GCP, regulatory requirements, and inspection readiness, including TMF documentation expectations related to Data Management.Experience contributing to cross-functional clinical teams. Strong organizational, communication, and problem-solving skills, with the ability to operate effectively in a fast-paced development environment.Experience managing data management deliverables across multiple studies and vendors.EEO Statement:MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.