Job Description

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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