Description
We are seeking an experienced EDC Design and Specifications Lead to join our team. As an EDC Design and Specifications Lead, you will be responsible for delivering EDC design and specifications within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data.
Responsibilities:
- Design and develop EDC systems, including Rave, Veeva, Inform, and other EDC systems
- Prepare and review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency
- Participate in sponsor meetings and audits/inspections
- Assign tasks and responsibilities to team members and optimize team capability
- Assist Managers in data collection for productivity, Quality, timelines, and resource planning
- Perform quality control procedures for specification development
- Conduct team meetings and provide guidance to Programmers and Data managers
- Maintain 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
- Conduct Quality Control of study design for assigned projects
- Participate in the validation of EDC studies when requested
- Create and maintain library objects within the Global Libraries
- Ensure compliance of standard objects usage throughout the business
- Manage standard objects within the Global Libraries
- Perform all activities related to specification development for study build and design of databases according to Standard procedures
- Review and approve derivations and edit checks requested by project teams
- Mentor study teams in CRF Design and specification development for leading EDC databases
- Oversee project work of junior staff
- Mentor and aid 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 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
- Complete work according to Fortrea SOPs, Work Instructions, and project-specific guidelines in accordance with Good Clinical Practice
- Meet with data managers on assigned projects to discuss technical strategies, contractual obligations, and timelines
- Provide consultation in database design and development with data managers
- Participate in the ongoing review of 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 resource levels required on a project
- Participate in the validation of new or updates to software
- Provide expert guidance to project teams, external clients, and internal clients within a global setting
- Provide feedback to management on the development potential of staff to assist in staff development
- Maintain awareness of new developments in EDC vendor products which may be applied to improve efficient use of these systems
- Implement processes as they are refined, or as new processes are developed and initiate and participate in ongoing review of processes to ensure continual improvement
- Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance
- Perform other duties as assigned
Qualifications:
- University/college degree in life sciences, health sciences, information technology, or related subjects preferred
- Minimum 6 years of relevant work experience, including data management and/or database programming and spec Design activities, including 4 years in Medidata RAVE, Oracle Inform, Veeva Vault, or equivalent EDC experience
- Fluent in English, both written and verbal
- Demonstrate excellent problem-solving skills, a proactive approach, and 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 relationship and regulatory obligation of CRO industry with pharmaceutical/biotechnological companies
- Demonstrated ability to work in a team environment
- Demonstrated ability to handle multiple competing priorities
- Proven interpersonal skills