- Responsible for the preparation and /or review draft and final eCRF specifications and edit check specifications for assigned projects to ensure quality and consistency.
- Assist in the development and implementation of solutions to DM service issues and concerns regarding Medidata RAVE, Oracle Inform, CRF Design, and Data Capture or imaging activities, including proactive prevention strategies.
- 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.
- Perform all activities related to specification development for study build and design of Medidata RAVE, Oracle Inform and other leading EDC databases according to standard procedures.
- Good organizational and time management skills with the ability to multi-task.
- Maintain awareness of new developments in EDC vendor products which may be applied to improve the efficient use of these systems.
- Responsible for performing quality control procedures for specification development.
- Participate in the validation of EDC studies when requested.
- Participate in the ongoing review of the processes used by the Data Management groups to ensure adaptation of best practices.
- Responsible for the creation and maintenance of library objects within the Global Libraries.
- Responsible for the management of standard objects within the Global Libraries.
- Responsible for the review and approval of derivations and edit checks requested by the project teams.
- Expected to assist with leading EDC Builds and mentor the study team in specification. development for Medidata RAVE, Oracle Inform, and other leading EDC databases.
- Mentor and aide in staff development, and achievement of competency standards.
- 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.
- Responsible for meeting with the data manager on assigned projects to discuss technical strategies, contractual obligations, and timelines. Escalate resource needs as appropriate.
- Participate in the ongoing review of the processes 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 with minimal direction.
- Provide feedback to management if any action is needed to increase utilization, improve efficiency, or amend the resource levels required on a project.
- Provide expert guidance to project teams, external clients and internal clients within a global setting.
- Perform other duties as assigned.
- 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).
- Minimum five years of relevant work experience to include data management and/or database programming activities including three years in 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.
- 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 managerial and interpersonal skills.
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