This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

16876-Sr Pre-Analytical Svcs Coord

IQVIA Holdings Inc.

Various Locations

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.

Job Overview

Provide technical expertise to internal IQVIA Laboratories departments to drive successful project implementation and
process improvement.
Essential Functions

• Responsible for following Health and Safety guidelines and policies at all times.
• Perform protocol-specific kit validation testing and documentation if applicable.
• Maintain metrics for the department, including required reporting and feedback to the appropriate personnel.
• Review essential documents e.g. protocol and other source documents and represent department at protocol-specific planning meetings.
• Communicate and advise department line management of all issues which will have a direct impact on the department.
• Provide cover to assist department in meeting daily requirements.
• Actively participate in SOP development and updates.
• Track deviations to minimize errors and/or drive process improvement.
• Manage accurate record maintenance and storage.
• Communicate protocol-related issues of study conduct to Project Services, Laboratory or other affected departments.
• Advise on matters related to quality issues.
• Provide information as needed in support of internal and external audits.
• Oversee remand metrics and identify study anomalies contributing to high remand rates.
• Feedback information to study related personnel.
• As required, track re-remand rates to identify areas for improvement.
• As required, co-ordinate and communicate with colleagues on matters related to project and sponsor-specific issues.
• As required, provide training and technical expertise to internal and external staff.
• Ensure all routine study related functions are completed accurately and on time as required by protocol, local procedures and applicable regulations, guidelines and standards.
• Assume full responsibility for planning, organizing and execution of relevant study related activities from initiation to database lock for multiple studies.
• Take appropriate actions to safeguard sample integrity (including labeling and storage) at all times in line with the regulatory standards and guidelines and local procedures.
• Prepare and package specimens requiring onward shipping to outside recipients for testing in line with local procedures.
• Ensure appropriate house-keeping activities are performed in order to maintain equipment in correctly functioning order and maintain a safe and healthy laboratory environment.
• Review, action and close any ad-hoc requests assigned.
• May manage inventory maintenance.
• May perform laboratory processing to include centrifuging, pipetting, and sample handling.
• Responsible for ensuring completion and recording of own training before carrying out procedures, as assigned.
• As required, provide training and technical expertise to internal and external staff.
• As required, provide input to the investigation of incidents
• As required, co-ordinate and communicate with colleagues on matters related to project and sponsor-specific issues
• As required, provide technical expertise to external customer.
Qualifications
• High School Diploma or equivalent or educaitonal equivalent Req
• 3 years relevant experience Req Or
• Equivalent combination of education, training and experience Req
• Good working knowledge of relevant procedures
• Ability to liaise with internal departments
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

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.

Job posted: 2020-10-22

3