Sr. Clinical Data Manager

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Adicet Bio, Inc is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CAR) and T cell receptor-like antibodies (TCRL), to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. For more information, please visit our website at http://www.adicetbio.com.

SR. CLINICAL DATA MANAGER

Responsibilities:

• CDM is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), Data review through database lock for phase 1-4 studies
• CDM has a broad, fundamental knowledge of the data management process and to plan, manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance
• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols)
• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design
• Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing
• Leads the development of internal Data Review Plan and coordinates the internal data listing review
• Coordinates the internal medical coding review
• Performs data listing review and generates/resolves queries in EDC
• Performs reconciliation of header data from external data sources against the clinical database
• Performs Serious AE reconciliation according to SOPs and guidelines
• Executes and/or distributes data management metrics, listings, and reports
• Manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts
• Reviews and provides feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans, and vendor specifications
• Provides training on the EDC system and/or CRF completion guidelines and EDC system at investigator meetings and to internal or external study team members, as needed
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial
• Maintains study DM related documents/files for inspection readiness
• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies)
• Participates in CRO/vendor selection process for outsourced activities
• Supports budget and resource planning across assigned projects
• Participates in the development, review and implementation of departmental SOPs, templates, and processes
• Participates in department or cross-functional initiatives

Qualifications:

• Bachelor’s degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field
• Minimum of five years of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Ability to handle multiple projects and prioritize effectively
• Well organized and detail oriented
• Can adapt to changes
• Open to new ideas and can think outside of the box.
• Proven ability to work both independently and in a team setting
• Oncology Experience a plus
• Medidita Rave Experience a plus 

Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.

Benefits:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.