Job SummaryServes as lead Clinical Programmer to manages and supports 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.
Core Responsibilities
1.Utilizes primary development tools including Oracle RDC, Oracle Inform, Medidata Rave, OmniComm TrialMaster, SAS, NCG CRF WorkManager, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
2.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 setup, edit check procedures, import setup and processing, export setup and processing, listings, and profile reporting.
3.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 criticism. 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.
4.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 profile reporting.
5.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, NGC CRF W/M, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.
6.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.
7.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.
8.Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed.
9.Performs system integration activities, application updates, and user acceptance testing.
10. 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.
11.Assists in project meetings and actively contributes and participates in departmental review meetings.
12.Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies.
13.Manages project resources, proactively alerting management of delivery and resourcing needs.
14.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.
Skills & Attributes
BS/BA degree in computer science or related field, and nominal experience, particularly in clinical programming and relational database development, or equivalent education and experience.
Clinical Data Management experience, CRO industry experience, programming proficiency in Electronic Data Capture (EDC) and data reporting, and/or transformation languages, e.g., PL/SQL, SAS, C#, or comparable field.
Familiarity with medical terminology and Good Clinical Practices preferred.
Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
Demonstrated experience in managing multiple priorities in a highly dynamic environment.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
About the Company:
INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.
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