Director Clinical Data Management

JOIN US. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at . Director, Data Management This Director, CDM position is a key role in the day-to-day management of Clinical Data Management activities. Including timely and professional ongoing management of clinical trial data for all relevant Phases. Represents Data Management in International Clinical team meetings for projects assigned. Defines project-level data management strategy and manages clinical trials and clinical projects assigned. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness. Manages external vendors providing clinical data. Prepares material for and presents at Investigator meetings. Performs Data Management tasks so that databases can be declared clean and locked according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Provides clinical data management oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers. Essential Duties/ Responsibilities Oversees all data management and clinical programming support activities for a clinical program for timely and accurate data acquisition, integration, analysis, and interpretation of results. Assure team is adhering to guidelines, budgets, and timelines of projects. Directs the development, review and implementation of SOPs, templates and processes and other departmental and/or cross functional initiatives. Recruits, trains, and manages employees and consultants within area of responsibility; Sets training standards. Acts as primary liaison with CROs, third party data vendors, EDC vendors. Reviews clinical protocols and CRO proposals Serves as primary reviewer or author of CRFs/ eCRFs, form completion guidelines, oversees and/or performs testing. Develops and is primary reviewer of Data Management Plans including Edit Check Specifications, Database Specifications, Coding Guidelines, Data QC processes. Ensures Data Management Plans are followed through the course of the studies. Sets and manages Data Management project timelines. Provides comprehensive status updates to biometrics and project team members. Implements data standardization and maintains data model across projects. Manages quality system applicable to requirements for clinical data management. Ensures users are qualified by education, training, and experience. Requirements Demonstrated proficiency in initiating and managing clinical data projects; global experience preferred. Knowledge of, and experience with databases, standards, medical terminology, medical coding dictionaries, quality control processes and auditing procedures Familiarity with GCP, ICH and FDA requirements as they apply to clinical data. Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH) Regular interaction with Clinical Operations, Biostatistics, Project Management and Quality Assurance groups Excellent written and oral communication skills required. Education/ Training Bachelor's or Master's Degree in Life Sciences, Computer Sciences, Mathematics, or health-related field Minimum of 15 years of Clinical Data Management experience in a regulatory environment with pharmaceutical product development 3 years of direct line leadership with proven ability of successfully performing as a therapeutic program lead and overseeing multiple clinical trials. 3 years of managerial experience desired CRO management experience Prior oncology/hematology and autoimmune experience highly desirable. Pay Range $182,000-$251,000 USD At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer. Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms. In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.