Senior Programmer Analyst

Job Overview:

Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tool like Medidata RAVE. Develop/validate Custom datasets 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 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 ,
• 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 .
• Serve as Programmer providing programming support for development and maintenance standards datasets.
• 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 work experience to include data management and database support.
• 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.

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