Clinical Data Manager

Responsibilities Serve as the Clinical Data Manager for assigned studies and/or lead specific, specialized data management workstreams (e.g., manual data review, external vendor data management) across multiple studies within a clinical program Participate in protocol and amendment reviews of assigned studies or program workstreams to ensure optimal CRF design and cross-study data standardization Partner with Clinical and Biometrics to develop or contribute to comprehensive Data Management Plans and Data Review Plans, covering all aspects of data collection, processing, reconciliation, review, and archival for the assigned scope Lead or support the design and build of the clinical databases and review tools to ensure they support clinical study objectives Responsible for user acceptance testing (UAT) within assigned study scopes or workstreams, including authoring and/or executing scripts Oversee or execute assigned aspects of data collection and review, which may include: monitoring data flow, performing discrepancy management, leading and participating in data review or reconciliation activities, and planning/facilitating database lock Manage timelines for assigned CDM activities to support corporate and clinical program objectives Ensure complete, accurate and inspection-ready CDM documentation within the assigned scope Ensure all CDM documentation are complete, accurate and inspection-ready state Act as team SME for key data systems and data streams, and process enhancement efforts Contribute to program deliverable timeline creation Performs additional duties as assigned Requirements BS/BA and/or MS degree Bachelor’s degree or equivalent combination of education/experience in science or health-related field with 4 years of direct data management experience (Rare disease experience highly desirable) Strong knowledge of CDM processes, EDC systems (Medrio and Medidata RAVE preferably), database programming, and quality management Understanding of the MedDRA and WHODRUG coding processes Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices Outstanding problem-solving abilities and influencing/negotiation skills Excellent interpersonal, communication, and leadership skills Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities Ability to prioritize and adapt quickly to changing business conditions with a positive attitude Willing to travel if required #J-18808-Ljbffr Jobtailor