Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within an assigned study or studies.
Provides data management expertise to the team in identifying opportunities for improvement.
Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
Demonstrates proficiency in the use of clinical and research-related computer programs.
Attends multidisciplinary conferences and workshops.
Schedules, prepares and participates in all pharmaceutical site visits.
Assists Research Nurse(s) and appropriate departmental, and laboratory staff in collection, storage, and shipment of patient specimens, radiology scans, reports, etc.
Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
Utilizes analytical thinking, attention to detail, and problem-solving skills.
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Performs other related work as needed.
Technical Skills or Knowledge:
Demonstrated ability to abstract subject data from medical record/source documentation and enter into care report forms and/or databases.
Experience generating and resolving queries and/or monitoring data.
Proficient in Microsoft Word, Excel and Adobe Acrobat.
Knowledge of medical and/or /clinical trial terminology.
Knowledge in relevant scientific field.
Handle competing demands with diplomacy and enthusiasm.
Perform research data management with minimal supervision.
Strong data management skills and attention to detail.
Work collaboratively and with divisional research offices.
Maintain a high degree of confidentiality with clinical data and client's proprietary data.
Adaptability to changing working situations and work assignments.
Ability to work independently and as part of a team.
Strong attention to detail.
Excellent multi-tasking skills.
Cover Letter (required)
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