Job Description:
Accountable for all data management tasks in support of high complexity clinical research studies independently.
Oversees document collection and review in collaboration with the Principal Investigator (PI), ensuring a high degree of confidentiality, while also providing expertise on the fundamentals of clinical research and related aspects of clinical studies to colleagues with less experience.
Solves complex problems relating to data management and the analysis of large administrative datasets.
Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.
Uses expertise by leading quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups and conducts root cause analysis, assists in development of preventative action plan.
Accountable for all tasks in complex clinical studies.
Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
Performs other related work as needed.
Preferred Qualifications
Education:
Bachelor's degree.
Experience:
Progressively responsible relevant clinical research experience.
Technical Skills or Knowledge:
Proven excellence in data management.
Perform data monitoring, query generation and query resolution.
Perform research data management with minimal supervision.
Knowledge of Microsoft Word, Excel and Adobe Acrobat.
Knowledge of medical and/or /clinical trial terminology.
Train junior data managers.
Experience troubleshooting clinical trials; uncovering issues and identifying the most appropriate intervention.
Knowledge in relevant scientific field.
Preferred Competencies
Strong analytical skills and attention to detail.
Handle competing demands with diplomacy and enthusiasm.
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.
Work independently and as part of a team.
Analytical skills.
Strong attention to detail.
Excellent multi-tasking skills.
Application Documents
Resume/CV (required)
Cover Letter (required)
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