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Senior Clinical Application Programmer (Remote)

Posted on Jun 14, 2019 by Covance

Durham, NC 27701
Health Care
Immediate Start
Annual Salary
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.
  • Participate in the evaluation and validation of new or updates to EDC software.
  • Ensure integration of Imaging development with OC studies
  • Provide expert technical guidance to project teams, external clients and internal clients within a global setting.
  • Prepare and provide internal training on advanced topics as needed in conjunction with senior management.
  • Advise management of changes in scope of projects to enable the timely development of change orders.
  • Implement processes as they are refined or as new processes are developed and initiate and participate in the ongoing review of the processes to ensure they are continually improved.
  • Provide feedback to management on the development potential of staff to assist in staff development.
  • Assist with interviewing and selection of potential candidates utilizing the DDI selection process.
  • Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems.
  • Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
  • Perform other duties as assigned.
Education/Qualifications Minimum Required:
  • 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 Minimum Required:
  • Minimum eight years of relevant work experience to include data management, database 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.

Reference: 720881010

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