General Summary of Position
Are you passionate about data and clinical research? We are actively recruiting for a strong research leader and data manager to join MedStar Health Research Institute in Washington, DC as Manager Outcomes Research. Effectively leads the project team, ensuring on-time, within budget, quality performance, and delivery of projects in collaboration with other leaders in the CRO.
Primary Duties and Responsibilities
- Collaborates with Center for MCRN Databases and Programming Technologies in case Report Form design, databases, and exports. Collaborates with the Center for MCRN Databases and Programming Technologies in preparation of queries and final report generation. Collaborates with the statistical support within MCRN to ensure the needs of the Scientific Leads are met.
- Collaborates with the Biostatistical team on the development of standardized variable exports for both retrospective and prospective databases.
- Communicates with internal departments and external organizations regarding database design and implementation.
- Develops complete accurate data entry tools established protocol and project timelines once for all databases and studies/trials. Prepares for study audits visits, as applicable. Completes all data queries within the timeframe preferred and/or required by sponsor. Ensures accuracy and completeness of information (both electronic and paper forms).
- Manages the following tasks completions: logging incoming case report forms, data clarification forms, edit checks, design and execution, serious adverse events notification, queries and study related report requests, resolution of data entry discrepancies, entry data clarification responses, and investigating data anomalies.
Minimum Qualifications
Education
- Bachelor's degree in related field required
- Master's degree preferred
Experience
- Excellent working knowledge of FDA, ICH, GCP and other regulatory functions required
- 3-4 years Experience in Phase I-IV clinical trials and knowledge of medical field required
Knowledge, Skills, and Abilities
- Excellent problem-solving skills and ability to exercise independent judgment.
- Business acumen and leadership skills.
- Strong verbal and written communication skills with ability to effectively interact with all levels of management, internal departments and external agencies.
- Working knowledge of various computer software applications.
This position has a hiring range of $70,428 - $124,467.
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