Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications.
Specifies, develops and validates applications supporting data capture and processing. First level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools.
Assists in monitoring internally and externally hosted applications for performance and / or system errors. Assists support team with customers as needed to support projects and applications externally.
Assists with management of external application vendor issues, integrations and implementations.
Utilizes primary development tools including Medidata, Rave, Oracle OC / RDC, Oracle Inform, and / or 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, programs, 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.
Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports
Provides application administration and technical support as the subject matter expert on core business packages including but not limited to : Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor / review, reporting tools, custom functions.
Ensures high quality deliverables by providing senior review of study level / program level / multi study 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;
manages and executes the change order to completion. Provides input and supporting details for change orders.
Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.
Performs system integration activities, application updates, and user acceptance testing.
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;
uses expanded technical skills to meet evolving project needs.
Assists in project meetings and actively contributes and participates in departmental review meetings.
Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.
Leads clinical programming activities on three (3) to ten (10) 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.
Bachelor’s degree preferred, or equivalent combination of related education and experience.
The ability to deal effectively with sponsors and internal customers at all levels.
Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
Demonstrated experience in managing multiple priorities in a highly dynamic environment
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%)