Covance

  • Senior Clinical Application Programmer

    Job Location(s) US-NJ-Princeton | US-NC-Raleigh-Durham | US-NC-Raleigh-Durham | US-IL-Chicago | US-TX-Dallas
    Job Number
    2018-18949
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    Mentor and aide in staff development, and achievement of competency standards

    • Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, and Oracle Inform,or other proprietary software, including proactive prevention strategies
    • Assist in development of global technical services competency models
    • Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design.
    • Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
    • Maintain technical competency through participation in internal and external professional seminars and participation in professional organizations.
    • Provide support and trouble-shooting of EDC systems, and act as the Biometrics liaison.
    • Provide support to data management for time and cost estimates and prepare and present to potential clients on global technical support capabilities.
    • Complete assigned work utilizing Medidata RAVE or Oracle InForm or other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices
    • Meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.
    • Provide leadership and consultation in the area of database design and development with data managers.
    • Review draft and final annotated data capture instruments and Physical Data Models for projects to ensure quality and consistency. Perform quality control procedures for database development.
    • Participate in the ongoing review of the processes used by the Technical Services Group to ensure adaptation of best practices.
    • Assist management with evaluation of new technologies as assigned.
    • Prioritize personal workload to meet specified completion dates and perform work without direction.
    • Conduct Peer Review/ Quality Control of study design for assigned projects.
    • Load standard client specific dictionaries in development area
    • Create, review and maintain objects in TMS Standard Domain.
    • Review and approve derivation and edit checks requested by the project teams. Discuss alternative programming for procedures, if appropriate.
    • Program, test, and maintain derivation and edit check procedures in the EDC environments.
    • Assist in developing and maintaining data loading procedures.
    • Provide input into assessments of resource requirements on a regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.

    Education/Qualifications

    • University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
    • Broad knowledge of drug development process
    • Basic knowledge of budgets and relationship to productivity targets

     

    • Thorough knowledge of the Oracle Clinical Data Management System to ensure the efficient integration and adaptation of imaging and remote data capture tools
    • Working knowledge of medical coding dictionaries and their application
    • Knowledge of time and cost estimate development and pricing strategies
    • Working Knowledge of System Validation Life Cycle in relationship to the implementation new applications

     

    • Fluent in English, both written and verbal

    Experience

    • support and dictionary support activities including five years Medidata RAVE, Oracle Inform, or equivalent experience
    • Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
    • Demonstrated skill in leading teams, by example and mentoring staff
    • Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis and communicate these clearly.
    • Excellent oral and written communication and presentation skills
    • Knowledge of clinical trial process and data management, biometrics, and systems applications to support operations
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
    • Demonstrated ability to work in a team environment
    • Demonstrated ability to handle multiple competing priorities

     

    • Proven managerial and interpersonal skills.

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