The Clinical Data Manager (CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock for assigned studies.
The core duties and responsibilities of the CDM are delineated below. Essential Duties/ Responsibilities Department Level: • Participates in the development, review and implementation of departmental SOPs, templates and processes • Supports budget and resource planning across assigned projects • Contributes to technical infrastructure of data management • Participates in CRO/vendor selection process for outsourced activities • May participate in department or cross-functional initiatives DM/Study Tasks: • Represents data management in study team meetings • 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, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols) • Executes and/or distributes data management metrics, listings, and reports, as required • Oversight of data management CRO/service providers on assigned studies • Monitors the progress of all data management activities on assigned studies to ensure project timelines are met • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external 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, able to work independently towards the assigned goal • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables Requirements • Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements • Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email • 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. • Proven ability to work both independently or in a team setting Education/ Training • Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field • Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement • CRO management experience desired • Competence in SAS programming a plus • Prior oncology/hematology experience highly desirable