Responsibilities:Member of clinical research team responsible for data management activities across multiple trials.Main responsibilities include design of Case Report Forms, development of edit check specifications, creation of test scripts and testing of study database, query processing, data reporting, putting in place data management plans, timelines and manage multiple projects through closeout and archiving.Activities also include assisting/leading with study start-up activities like training sites, internal users and attendance in clinical project meetings.Perform data management activities on both Electronic Data Capture (EDC) and paper studies.Performs as lead data manager for projects and/or programs.Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.Work closely with clinical project team and database programmers to provide edit check requirements and specifications at the time of study database development and Postproduction changes.Ensure data quality by CRF data review, preparation for entry, query processing, discrepancy management, ad-hoc reporting, listing generation.Create and maintain all essential data management documentation including, but not limited to, data management plans, Data Review guidelines, CRF completion guidelines, Data Entry guidelines, UAT plans and other study specific work instructions or guidelines for multiple projects.Perform study user acceptance testing and database QC.Collaborate with CDMs and other staff as necessary.Act as a point of contact with vendors such as Database developers, coders, Safety personnel, QA, Core Labs, etc.Assist in overall project tasks such as process flowcharts, Standard Operating Procedures (SOP), work instructions, training guidelines, etc.understanding of regulations (ex ICH and GCP) and clinical terminology.Analytical skills (output interpretation).Intermediate/skill/knowledge in adhoc data reporting, data review listing development, metrics reporting, distribution and review.Sufficient understanding of key analytical end point needs contributes to review of draft/ final tables, listings, figures and review of interim/final clinical study reports (where applicable).Oversight of major data management activities includes - communicating study specific coding needs and timing to the Coding Specialist.Ensures the exchange of data between the clinical database and the coding tool is set to run on a regular schedule (e.g., nightly, weekly, etc.).Ensures coding reviews/discrepancy actions are applied by the Coding Specialist and Data Management as needed.Requirements:Clinical Database Systems Knowledge - EDC and Paper.Intermediate to Advanced level proficiency with relational databases in either paper or electronic data capture (EDC) systems.Big-picture and detail-oriented view of data management processes, tools and procedures.Becoming aware of and participating in more standardization of objects and processes, e.g., design of standard case report forms, reusable edit check specifications, study data management metrics, templates as well as data management timeline templates across studies to gain efficiency in data collection and reporting.Overall understanding of regulations (e.g., ICH, GXP, ISO) and more advanced understanding of FDA, GXP and Quality audits that involve Data Management, if required.Knowledge of coding process and coding tools.Knowledge of coding process (performed by Medical Coder).Bachelor's Degree and a minimum of 3-5 years related experience in a medical device and/or pharmaceutical data management environment.Computer proficiency in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, Clindex, CRF design tools etc.Proficient Data management skills on various types of clinical trials (Pharma and/or Device).Experience with reporting tools.TOAD, Discoverer, Crystal Reports, Clindex Reports, etc.).Excellent organizational skills and attention to detail.Minimal travel may be required (10-20%).Computer proficiency in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, Clindex, CRF design tools etc.Proficient Data management skills on various types of clinical trials (Pharma and/or Device).Experience with reporting tools.TOAD, Discoverer, Crystal Reports, Clindex Reports, etc.).Excellent organizational skills and attention to detail. Katalyst HealthCares & Life Sciences
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