Senior Custom Function Programmer

About the Company:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

About the Role:

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.

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:

• 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 bachelors degree.
• Fluent in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Required Skills:

• 5 to 8 years of relevant hands-on experience in Custom function programming including complex scenarios.
• 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

• Office work environment.