Senior Edit Check Specialist - IQVIA Biotech

IQVIA Biotech is seeking a Sr. Edit Check Specialist for a homebased opportunity!

BASIC FUNCTIONS:

Create and update data validation edit check specifications based on study protocol requirements, corporate standards, best practices, and feedback from internal and sponsor teams. Develop training materials and assist with the update of edit check development work practices as needed.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Interpret the study protocol for use of edit check design and specification.
• Assist in the creation of the study build timeline.
• Develop the edit check specifications for each assigned project based on protocol and study team requirements, standards, and best practices.
• Communicate frequently with all stakeholders involved to ensure timelines and expectations are met.
• Facilitate both Internal review meeting as well as Sponsor review meeting to discuss any outstanding issues with edit check development.
• Respond to any clarifications or issues that are highlighted during the edit check programming and QC processes.
• Communicate any project risks to the lead data manager, including the potential for missing a planned timeline and working outside of the original budget or scope-of-work expectations.
• Escalate potential quality issues to management.
• Comply with all training and standard operating procedures (SOPs) for the position.
• Responsible for multiple study design projects at the same time.
• May work on projects across multiple trial EDC platforms.
• Train and support junior Edit Check Specialists to ensure they have necessary skills to meet their deliverable.
• Identify areas for process improvement and actively participate in process improvement initiatives as assigned by manager.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process and methodology.
• Knowledge and understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
• Ability to supervise resources and plan tasks for edit check development with the support of management.
• Ability to work creatively and independently to carry out assignments of a complex nature.
• Ability to manage multiple project timelines and regularly switch between projects as required to meet timeline deliverable expectations.
• Ability to communicate and work effectively and cooperatively with fellow employees and with sponsors.
• Ability to learn new technology and tools that will facilitate the clinical trial process.
• Ability to train other staff.

MINIMUM RECRUITMENT STANDARDS:

• Degree in biological/life sciences with a minimum of 5 years of work experience as a lead clinical data manager.
• Excellent interpersonal and organizational skills required.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.