Job Overview:
Performs independent programming activities (using Medidata Rave) on multiple projects concurrently with less or no support from Senior Programmers. Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or VEEVA. Create CRF Annotations and programming specifications for datasets creation using transfer / guidelines / CDISC / Client Standards.
Summary of Responsibilities:
Performs independent programming activities on multiple projects concurrently with less or no support from Senior Programmers. Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or VEEVA
Read understand requirement documents/Specifications, database design. Reports design and conduct quality control processes including database review to meet client requirements.
Produce Define XML/pdfs, annotated ECRFs and Reviewers Guide for submission deliverables.
Develop visual analytics dashboard using tools like Spotfire/Tableau.
Perform any post-production changes, publish checks, complex structure dynamics, Rave Safety Gateway, Balance (RTSM) mapping setting to the EDC database or enhancements to the programs like edit checks, listings, Protocol Deviations, etc.
Complete assigned work utilizing EDC tools or other proprietary software according to Fortrea sops, Work Instructions and Instructions, project, and project specific guidelines in accordance with Good Clinical Practices.
Train and mentor, the team on EDC tools as required and have them ready to perform independent enough on day-to-day activities.
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.
Develop/Validate programming specifications for generation of datasets as per Client/CDISC standards.
Program edit checks/quality checks on source data and communicate data issues to data management.
Perform quality check and ensure the work is delivered with quality and with knowledge of regulations pertaining to computerized systems to ensure compliance.
Continuously learn and improve communication, technical and problem-solving skills.
Interact with project team members in related discipline and provide solutions to the operational issues.
Able to work independently on multiple sponsors and take initiative to accept new challenges in Clinical Programming Applications.
Reconcile database build, project files, reports, listings, and other documents related to programming for accuracy, completeness of Data Management processes.
Work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision of Sr. Programmers.
Perform other duties as assigned by Manager.
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.
Experience (Minimum Required):
4 - 7 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.
Ability to work effectively under minimal supervision.
Ability to prioritize work and Self-motivation.
Good 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.
Preferred Qualifications Include:
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Physical Demands/Work Environment:
N/A
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