- Assist in the development and implementation of solutions to DM service issues and concerns regarding Medidata RAVE, Oracle Inform, CRF Design, and Data Capture or imaging activities, including proactive prevention strategies. Develop and maintain programs for creation of datasets as per specifications. Create CRF annotations and Mapping specifications as per CDISC/Sponsor datasets. Develop programs to import external data and transform to Excel files for data review and reconciliation. Maintain study databases for assigned projects.Perform programming for any regular or ad-hoc reports/listings as needed by the Study/Sponsor teams using available tools/Spotfire.
- Summary of Responsibilities:
- Proactively learn to design and execute processes related to programming, setup, support of clinical and/or safety databases like Medidata Rave or Oracle Inform.
- Perform the following duties with the guidance from Senior staff: Database design, EDC edit programming, listings, ad-hoc/scheduled reports using Cognos/Business Objects – XI, R and other tools for data cleaning and reporting.
- Complete assigned work utilizing EDC tools or other proprietary software according to Fortrea SOPs, Work Instructions, and project-specific guidelines in accordance with Good Clinical Practices (GCP).
- Maintain knowledge and awareness of latest developments in CDISC standards and Statistical programming.
- Create CRF annotations and mapping specifications as per Clients/CDISC standards.
- Dataset or Excel files for data review and reconciliation.
- Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance and interact with project team members in related discipline.
- Continuously learn and improve communication, technical, and problem-solving skills.
- Provide regular status updates on the tasks assigned to Line Manager.
- All other duties as needed or assigned.
- Qualifications (Minimum Required):
- University/college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluent in English, both written and verbal.
- Experience (Minimum Required):
- 3-5 years of relevant work experience to include data management and database support: EDC systems programming.
- Good problem-solving skills and a proactive approach.
- Good oral and written communication skills.
- Good knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
- Ability to work in a team environment and under minimal supervision.
- Ability to prioritize work and Self-motivation.
- Appropriate time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of quality work.
- A cooperative and team-oriented approach.
- Physical Demands/Work Environment:
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