Job Description

• Main responsibility includes 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 study 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.
• Participate in project meetings to give a status update to project managers and upper management.
• Collaborate with Medical coder to ensure accurate and consistent clinical reporting of clinical terms to assign a validated terminology in prep for analysis and reporting to regulatory authorities.
• Ensure good Clinical Data Management practices to support data quality and audit readiness.
• Ensure necessary data exchanges have occurred as scheduled.
• Product Knowledge/Therapeutic Expertise.
• Seek out adequate training on products and therapeutic areas in alignment with assigned studies and ensure proper training documentation is completed/maintained.
• Basic ability to contribute and/or interpret protocol to create CRFs and edit check spec.
• 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.
• Written and verbal communication skills (for documentation and customer interaction).
• Proficiency in organizational skills and attention to detail to clearly and succinctly write and verbalize in a variety of communication inter-office and remote settings and styles (e.g., documentation, general correspondence, presentations, meetings, trainings etc.).
• Also oversees and assists in preparation of study material for investigator, study coordinator and monitor meetings, if applicable.
• Other duties as assigned.
• Comply with written procedures, instructions, SOPs, and other documents.
• Will work primarily within Clinical Affairs but may have to interact with the Quality and Regulatory Affairs staff.
• May interact with outside vendors.
• Scope will include multiple clinical studies at a time.
• Comply with written procedures, instructions, SOPs, and other documents.

• 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.
• 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 (e.g. 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).

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