Senior Principal Clinical Programmer (South Africa) Hybrid/Remote
Job Description
Updated: Yesterday
Location: ZAF-Bloemfontein
Job ID:
Senior Principal Clinical Programmer (South Africa) Hybrid/Remote
Job Responsibilities
- Provides clinical programming technical support and expertise across the DM/Clinical Programming function and other departments.
- Provides application administration and technical support as the subject matter expert on core business packages (Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS) and supplemental packages such as migration mentoring, reporting tools, and custom functions.
- Utilizes primary development tools to design, write, validate, and maintain software to meet specifications in a timely manner following standard development procedures.
- Generates and maintains documentation including specifications, coding, and validation efforts for annotated CRFs, database creation, coding setup, edit checks, import/export setup, listings, and custom reports.
- Monitors applications for workflow alerts, system errors, performance issues and troubleshoots programming deliverable defects.
- Performs system integration activities, application updates, and user acceptance testing.
- Serves on project teams to coordinate and lead development activities for clinical programming projects, attends meetings, and provides analytical problem solving and constructive feedback.
- Communicates project issues that might impact target dates, scope, or budget to management and escalates potential problems promptly.
- Participates in and provides input at project review and departmental review meetings, and may represent the department at client meetings or senior management status update meetings.
- Ensures high quality deliverables by providing senior review of program level and multi study core deliveries, attends sponsor audits, and assists with in progress audits.
- Reviews and provides input on study budgets, manages project level metrics, progress, and status, especially for large programs of studies; monitors scope vs. actual work and manages change orders.
- Provides leadership, mentorship, training, guidance, and support to other department members based on expertise in specific skill sets.
- Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies.
- Provides leadership/oversight of 5 to 20 concurrent studies, including oversight of other lead programmers and their associated studies.
- Manages project resources, proactively alerts management of delivery and resourcing needs.
- Assists with management of application vendors, monitors vendor SLAs, and reports metrics to upper management.
- Supervises implementation of upgrades and new modules of remotely hosted vendors, acquiring documentation and storing it in the relevant areas.
- Maintains broad overall knowledge in clinical programming and data management through literature, self training, and professional development.
- Contributes to the update of standard operating procedures and work instructions, and proposes and leads development of process improvements and new concepts, technologies, and products to meet emerging customer needs.
Qualifications
- Bachelor's degree in a related field; Master's degree preferred; in lieu of a Bachelor's degree, equivalent education and experience.
- Ability to deal effectively with sponsors and internal customers at all levels.
- Experience in clinical Metadata Repository (MDR) and programming languages (PL/SQL, SAS, C#, or VB).
- Excellent communication and interpersonal skills, both written and spoken.
- Demonstrated experience in managing multiple priorities in a highly dynamic environment.
- Experience working in a matrix structured environment (preferred).
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
- Experience in mentoring others in the clinical trial process.
- Ability to read, write, speak, and understand English.
Summary
Serves as lead Clinical Programmer to manage and support all functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverables while leading less experienced programmers. Demonstrates a high degree of independence, technical skill, and the ability to influence the team and clients to achieve results with minimal supervision. May determine overall strategy for clinical programming tasks within a program, identify trends across projects, and take appropriate action to replicate positive results and mitigate negative ones. Supports clinical programming and data management staff for EDC, reporting, and processing tools, proactively monitors applications, and manages external vendor issues, integrations, and implementations.
Equal Opportunity Employer Statement
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at: Email:
About This Role
Career insights for Clinical Data Managers positions