Job Overview:
Responsibility for delivering EDC design and specifications within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data. Document and maintain contents of the standards library as required. Lead eCRF Design within the scope of assigned projects. Assist in the management, documenting and maintaining of the standards library as required.
Summary of Responsibilities:
- 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 Fortrea 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 time lines. Escalate resource needs as appropriate.
- Provide consultation in database design and development with data managers.
- 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.
- 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 the efficient use of these systems.
- 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 work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
- Perform other duties as assigned.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluent in English, both written and verbal.
Experience (Minimum Required):
- 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.
Preferred Qualifications Include:
- 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.
- 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.
Physical Demands/Work Environment:
- Office or home-based work environment.
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