Department: Clinical Informatics
Reports To: Manager, Associate Director, Clinical Informatics
Bachelor’s degree in engineering or science and 5+ years of relevant experience in database design and edit check programming. RAVE Experience is must.
The clinical Database Programmer is responsible for all technical aspects of study build, validation, and maintenance, including clinical programming activities for new and ongoing clinical studies, start-up activities, database revisions, timely resolution of technical issues related to the conduct and closeout of clinical studies. Database Programmer works collaboratively with Data Management and multiple functional groups to complete programming tasks per agreed upon timelines.
Essential Functions of the job:
- Utilizes development tools to design databases in EDC (Medidata Rave must) and helps manage the lifecycle of the study database
- Serve as a primary technical point of contact for assigned studies
- Works closely with data management to develop eCRF specifications following CDISC/SDTM/CDASH format and automated edit checks
- Liases with the IT and QA groups to ensure tight communication, adequate support and quality deliverables
- Generates and maintains all required documentation, including specification versions, programming and validation efforts, in support of database build and maintenance
- Helps to maintain standard library of eCRFs and edit checks in the database design tool
- Troubleshoots issues with EDC, working with the EDC vendor as needed
- Revises the EDC database, as applicable, during study conduct
- Helps develop database programming SOPs and templates
- Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and standards
- Serves on project teams to coordinate and lead development activities for clinical programming projects
- Attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables
- May provide mentorship to 1-3 programmers and Data Managers
- Escalates issues that may impact target dates or budget to management in a timely manner
Manage and provide leadership to database programmers
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Travel: None to Minimal