Senior Lab 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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Essential Functions
• Assist in the development of database design requirements, including configuration (e.g. project specific kit contents, laboratory events, requisitions, medical reports) and programming for full protocols and protocol amendments.
• Conduct configuration and programming reviews; lead in database verifications while adhering to database design requirements.
• Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues.
• Lead set-up activities and communications with client and or Sponsor counterparts, assist project coordinators in resolving queries and identify and escalate issues as required.
• With supervision, mange the entire set-up process for a one region, low complexity study with the oversight of a project manager.
• Coordinate set-up activities across data management, logistics, clinical trial materials, laboratory testing, and specimen management.
• Create and maintain project set-up updates to project tracking database, actions/issues log, and status sheets
• Use knowledge of protocol specific and routine tasks to ensure outputs are delivered in line with organizational standards and client expectations.
• Coordinate information and communications for set-up activities with clients and internal customers to ensure approvals are met, launch is successful and a smooth, event free, handover to project services colleagues.
• Perform technical reviews and feedback comments and changes to project managers.
• Contribute to process improvement initiatives.
• Maintain accurate project documentation.
• Mentor and assist in training more junior staff,
• May host Project Launch meetings or other internal meetings on behalf of Project / Set Up Manager.
• May provide back-up support on behalf of colleagues who are absent from the office.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications
• Bachelor's Degree  Req
• 1-2 years’ relevant experience Req Or
• Equivalent combination of education, training and experience Req
• 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, presentation, and spreadsheet applications
• Demonstrated ability to work in a fast-paced, high stress environment highly desirable
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Requires protocol specific knowledge
• Ability to work with limited support through complex global trials
• Knowledge of Q2 Solutions processes and computer systems helpful

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.