Senior Techinical Designer

Job Overview:

Senior Technical Designer(Senior Rave Programmer)-Remote
  • Responsible for designing the eCRF in leading EDC systems including Rave, Veeva, Inform or
    other EDC systems.
  • Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency.
  • Follow attention to detail approach and participate in sponsor meetings and audits/inspections.
  • Assign tasks and responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business.
  • Assist Managers in data collection for productivity, Quality, timelines and resource planning.
  • Responsible for performing quality control procedures for specification development.
  • Conducts team meetings and provide guidance to Programmers and Data managers.
  • Responsible for maintaining study specifications for assigned projects.
  • Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
  • Advance competency through participation in internal and external professional seminars and symposiums.
  • Responsible for conducting Quality Control of study design for assigned projects.
  • Participate in the validation of EDC studies when requested.
  • Responsible for the creation and maintenance of library objects within the Global Libraries.
  • Responsible for ensuring compliance of standard objects usage throughout the business.
  • Responsible for the management of standard objects within the Global Libraries.
  • Perform all activities related to specification development for study build and design of databases according to Standard procedures.
  • Responsible for the review and approval of derivations and edit checks requested by the project teams.
  • Mentor the study team in CRF Design and specification development for leading EDC databases.
  • Oversees the project work of junior staff.
  • Mentor and aide in staff development, and achievement of competency standards.
  • 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, standards maintenance, and/or change control.
  • Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities.
  • Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
  • Complete work according to Covance SOPs, Work Instructions and project specific guidelines in accordance with Good Clinical Practice.

#LIREMOTE

Education/Qualifications:

  • University / college degree (life sciences, health sciences, information technology or related subjects preferred).
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
  • Fluent in English, both written and verbal


Experience:

  • Minimum 6 years of relevant work experience to include data management and/or database programming and spec Design activities including 4 years in Medidata RAVE, Oracle
    Inform, Veeva Vault or equivalent EDC 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.
  • Excellent oral and written communication and presentation skills.
  • Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.
  • 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 interpersonal skills.


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