Mentorand 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.
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
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
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.