Clinical Programmer II (Medidata RAVE EDC)

Job Summary

Clinical Programmer II (Medidata RAVE EDC)

Job Responsibilities

• Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
• 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, focuses on deliverables, and provides constructive feedback.
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Ensures quality deliverables by providing review of study level core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders.
• Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications, and uses expanded technical skills to meet evolving project needs.
• Assists in project review meetings and assists with departmental review meetings.
• Attends Quick Start Camps (QSCs) as the lead clinical programmer for assigned studies.
• Leads clinical programming activities on up to eight (8) concurrent studies depending upon scope, similarity, program, and resourcing requirements.
• Manages project resources, proactively alerting management of delivery and resourcing needs.
• Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.

Qualifications

• Bachelor's degree preferred, or equivalent combination of related education and experience.
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Minimum 3 years of relevant experience in Rave EDC build experience is mandatory.
• Must have experience in CRF build or screen build, edit checks programming.
• Must have good knowledge about GCP, good clinical practices.
• Migration and Custom Function experience is a plus.
• Experience working in a matrix-structured environment is preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail.
• Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.
• Ability to travel as necessary (up to 25%).

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