Supports Clinical operations and assists in the design, development of agreed deliverables at study level, on time and in adherence with internal and client quality standards. Maintain knowledge and awareness of latest developments in CDISC standards and Statistical programming as needed. Development and maintenance of Clinical EDC Database like Rave, Inform and/or other EDC tools. Creation of SAS Programs per specifications as needed (example for Data Extraction, Transformation, and Loading of Clinical Data from EDC and External files, Clinical report etc.). Develop and maintain SAS programs for creation of SAS datasets.
Summary Of Responsibilities
Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems such as Medidata Rave, Inform and other EDC systems.
Deliver per agreed deliverables at a study level on time and in adherence with internal and client.
Maintain knowledge and awareness of latest developments in CDISC standards and Statistical programming as needed.
Develop and maintain SAS programs for creation of SAS datasets as needed.
Complete assigned work utilizing EDC tools or SAS or other proprietary software according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.
Perform all tasks 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.
Perform other duties as assigned by Managers and/or Senior Programming staff.
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.
Fluent in English, both written and verbal.
Experience (Minimum Required)
0 - 2 years of relevant work experience to include data management and database support EDC systems programming or SAS programming or any programming experience.
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 maintain the highest standards of quality work.
A cooperative and team-oriented approach.
Physical Demands/Work Environment
Office work environment.
Remote/Homebased
Learn more about our EEO & Accommodations request here.
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