Senior Technical Designer

Overview

Responsible for EDC design and specifications within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data. Leads eCRF design and maintains the standards library.

What you'll do

• Design the eCRF in leading EDC systems including Rave, Veeva, Inform or other EDC systems.
• Prepare and/or review draft and final eCRF and edit check specifications for assigned projects to ensure quality and consistency.
• Conduct quality control of study design and specification development for assigned projects.
• Maintain study specifications for assigned projects.
• Create and maintain library objects within the Global Libraries and ensure compliance of standard object usage across the business.
• Review and approve derivations and edit checks requested by project teams.
• Participate in sponsor meetings, audits and inspections.
• Assign tasks and responsibilities to team members, conduct team meetings and provide guidance to programmers and data managers.
• Mentor the study team and junior staff in CRF design and specification development, and aid in staff development and competency achievement.
• Assist with development of training programs and present training to technical staff on study build, standards maintenance and/or change control.
• Assist managers in data collection for productivity, quality, timelines and resource planning.
• Participate in validation of EDC studies and of new or updated software.
• Participate in development of global, harmonized SOPs and work instructions for technical service group activities.
• Notify project leadership of out-of-scope work requests and advise management of scope changes to enable timely change orders.
• Complete work according to Fortrea SOPs, work instructions and project guidelines in accordance with Good Clinical Practice and regulations pertaining to computerized systems.
• Meet with data managers on assigned projects to discuss technical strategies, contractual obligations and timelines, and provide consultation on database design and development.
• Provide expert guidance to project teams and internal and external clients in a global setting.
• Prioritize personal workload to meet completion dates and work with minimal direction.
• Provide feedback to management on resource levels, utilization, efficiency and staff development potential.
• Keep up with new developments in EDC vendor products and assist with evaluation of new technologies as assigned.
• Perform other duties as assigned.

What you'll need

• University or college degree in life sciences, health sciences, information technology or related subjects preferred; relevant experience and/or education equating to a bachelor's degree will be accepted in lieu of a bachelor's degree, and relevant equivalent experience may be considered in lieu of educational requirements.
• Fluent in English, both written and verbal.
• Minimum 6 years of relevant work experience including data management and/or database programming and specification design activities.
• Minimum 4 years in Medidata RAVE, Oracle Inform, Veeva Vault or equivalent EDC experience.
• 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, and CDISC.
• Working knowledge of the relationship and regulatory obligations of the CRO industry with pharmaceutical and biotechnology companies.
• Demonstrated ability to work in a team environment and to handle multiple competing priorities.
• Proven interpersonal skills.

Nice to have

• University or college degree in life sciences, health sciences, information technology or related subjects; relevant experience and/or education equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
• Minimum 6 years of relevant work experience including data management and/or database programming and specification design activities, including 4 years in Medidata RAVE, Oracle Inform, Veeva Vault or equivalent EDC experience.
• 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, and CDISC.
• Working knowledge of the relationship and regulatory obligations of the CRO industry with pharmaceutical and biotechnology companies.
• Demonstrated ability to work in a team environment and to handle multiple competing priorities.
• Proven interpersonal skills.

Details

• Location: Bangalore.
• Work environment: office or home-based.