Senior Laboratory Project Set Up Coordinator

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s);ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration.

RESPONSIBILITIES

• Assist with study validation activities
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements
• Configure project database, where applicable
• Maintain accurate project documentation files
• Keep Setup Managers, Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project
• Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings)
• Participate in local and global improvement projects as defined by the relevant process improvement management team
• Participate in internal audits, as required
• Communicate with study Sponsor(s) as needed (e.g. exchanging factual information)
• Assist in the development of database design requirements for protocols and protocol amendments
• Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues
• Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
• Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice.
• Accountability and ownership for the quality of database configuration.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelors degree required

• Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry or equivalent combination of education, training and experience.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good organizational and operational skills

• Good accuracy and attention to detail skills

• Good written and verbal communication skills including good command of English language

• Computer proficiency in word processing and spreadsheet applications

• Ability to establish and maintain effective working relationships with co-workers and managers. 

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.