INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post: Principal Clinical Programmer
Responsibilities
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
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Qualifications Requirements :
- Bachelor Degree in Science or health care field.
- Experience in clinical data management in a CRO setting with SAS programming proficiency.
- Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Additional Information:
Qualification: Bachelor Degree in Science
Location:Gurgaon
Industry Type: Pharma
Functional Area: Clinical Programming
Last date: 25th July, 2016
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