Job Overview
Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tool, Medidata RAVE. Develop/validate Custom datasets (CF) and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database, Conduct Peer Review/Quality control of study design for assigned projects.
Summary Of Responsibilities
- Lead the development and implementation of Clinical solutions to global technical services issues and concerns regarding EDC tools or SAS programming.
- Complete assigned work utilizing Medidata Rave according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.
- Perform any post-production changes to the EDC database or enhancements to edit checks, listings, Protocol Deviations, etc.,
- With assistance, meet with Data Manager on assigned projects to discuss contractual obligations and timelines.
- Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to EDC tools.
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
- Participate in the ongoing review of the processes used to ensure adaptation of best practices.
- Conduct Peer Review/Quality control of study design for assigned projects.
- Able to work independently and take initiative to accept new challenges in Clinical Programming Applications, also participate in the validation of new or updates to software.
- Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems.
- Resource forecasting and allocate activities to the team members on the project.
- Proactively identify trends, generate reports/metrics, or demonstrate programming processes to sponsors/auditors (if required), assist with the design of ECRFs and other study documents.
- And all other duties as needed or assigned
Qualifications (Minimum Required)
- University / college degree (life sciences, health sciences, information technology or related subjects preferred).
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
- Fluent in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
- 5 to 8 years of relevant hands-on experience in Custom function programming including complex scenarios.
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- Good problem-solving skills and a proactive approach.
- Good oral and written communication skills.
- Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
- Demonstrated ability to work in a team environment.
- Demonstrated ability to work independently under supervision.
- Proven interpersonal skills.
Physical Demands/Work Environment
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