Clinical Data Management

3 weeks ago

Edison NJ, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities : Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications Designs, modifies and manages study eSource documents Generates routine and ad-hoc reports using internal and external data sources Prepares and distributes project status reports to project team and management Contributes in the development, review, and implementation of departmental SOPs, Work Instructions, templates, guidelines, etc. Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements Participate in cross-functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback Provides training to internal or external team members, as needed Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable Performs coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager and Medical Monitor Participates in the selection of suitable vendors for the outsourcing of DM activities, and for building effective DM vendor relationships. This includes being involved in request for proposals, contract negotiations (budgets, task orders and timelines) and selection of DM and/or technology, as needed Supports clinical Data Management deliverables generated by external vendors (e.g., CROs) for outsourced study activities such as CRF design, database set-up activities, database specifications, data validation process, User Acceptance Testing, training of study site personnel in CRF completion, and data clarification processes Oversee data cleaning activities and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT) Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission Presents information in a concise, user-friendly format by determining target audience needs to support decision processes outcomes Requirements : Bachelor's Degree or master's degree in math, science, health-related field or equivalent experience Clinical Data Management 3+ years' experience across Phase 1-4 clinical trials Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices EDC experience in multiple systems Ability to deliver results and execute required activities individually and in a team setting Organized and detail-oriented Strong written and verbal communication skills in a compact clinical team working with aggressive timelines Highly responsive and proactive team player with a desire bring leadership skills into a rapidly growing company

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