The posting
Job Overview:
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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