Sr.manager, Clinical Data Management
Listed on 2026-06-26
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IT/Tech
Data Analyst, Information Security & Data Protection, Data Scientist, Data Science Manager
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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at
JOIN US!
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at
Sr. MANAGER, CLINICAL DATA MANAGEMENT
Adicet Bio is seeking a highly skilled and experienced hands-on Sr. Manager of Clinical Data Management (CDM) who will be responsible for providing technical expertise and overseeing DM work performed by CROs. The Sr. Manager CDM is expected to have extensive experience in Data Management from DM Study Starup through Database Lock and Archiving.
Responsibilities Will Include
- Review of all DM related documents for completeness, technical accuracy and adherence to DM current best practices. These include CCGs, DMPs, DVSs, DRPs, Coding Guidelines, DTSs, etc.
- Knowledge of CDISC Standard including CDASH for eCRF Development and CDISC current Codelists for eCRFs
- Expertise in working with Microsoft Excel. Ability to download Reports from Medidata RAVE to create summary reports for Study Teams using filters, sorts, pivot Tables and graphical displays of outliers and data inconsistencies.
- Experience with downloading and reviewing raw eCRF data from Medidata RAVE as part of oversight.
- Development and finalization of Data Transfer Specifications (DTSs) with external vendors for central Lab data, Imaging Data, Biomarkers, etc.
- Knowledge of EDC systems including Medidata RAVE with experience on EDC Setup, UAT, ALS, Custom Functions, Coding, PD Module, Standard and custom reports on quality and timeliness of DM tasks, etc.
- Oversight and management of CROs including managing timelines and effective communications. Providing feedback to internal and CRO team members for accountability and building high performance teams.
- Internal communication and collaboration with study teams and Sr. Management for DM activities. Review and provide to internal teams, DM performance and aging reports on data entry completion, missing pages, query resolution, clean patients, etc. Follow-up with CROs, Clin Ops, CRAs and CRCs as needed to avoid backlog and meet internal analysis requirements.
- Generate Agendas, Minutes and Action Items for internal meetings.
- Experience with Development of internal Work Instructions, Templates, SOPs, Checklists as needed
- Experience with CAR-T, Oncology, Auto-immune diseases a plus
- Experience with Master Protocols a plus
- Experience with EDC Builds including custom function programming a plus
- Knowledge of CDISC SDTM and ADaM including TAUG’s a plus
- Knowledge of GCDM Practices a plus
- Familiarity with 21
CFR Part 11, 50, 54 312, 314; applicable FDA Guidelines including 2024 guideline on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations a plus - Familiarity with ICH E3R1, E5R1, E6R3, E8R1, E9, E9R1, E14, E17, E19 a plus
- Bachelors or Masters degree in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields
- 8+ years of experience in CDM within pharmaceutical/biotechnology industry from study setup, conduct through database lock for Phase 2 or 3 studies.
- Deep expertise in CDM and associated technologies, processes and tools.
- Understanding of regulations and guidelines including ICH E6 GCPs, CDASH, CDISC as applicable to CDM
- Autoimmune or Oncology clinical trial experience is strongly preferred
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