Senior Technical Services Specialist - will be an onsite role longer term (12 month Fixed Term Contract)

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.

Overview

Act as a specialist for pulling requirementsto set up test code in the laboratory systems (including LIS and Protocol Management systems) and provide technical guidance on the design of the clinical trial database in collaboration with Project Services, Global Laboratory Teams, Translational Science Laboratory, Scientific Review, Data Management, Quality Assurance, Global Database Operations and Information Technology teams as necessary. Provide technical and scientific expertise for any pre- and post-analytical queries raised by internal study teams.

Essential Functions and Responsibilities

§Reviews laboratory testing and test code requirements for new studies.

§Responds to technical inquiries and provides technical documents and data either directly or by maintaining study specific databases.

§Attends internal study design meetings to discuss testing requirements, test code availability and highlight potential challenges.

§Submits requests for new test codes or amended test codes via the TCWA system.

§Monitors the Technical Services Database ticket system to perform test code loading into clinical trial database and the completion of Blood Volume Charts.

§Monitors the Technical Services ticket system responding to inquiries from other departments requesting specific laboratory or testing information.

§May draft new standard operating procedures (SOPs) and assist in the maintenance of existing SOPs related to the departmental activities.

§Assist in Quality Assurance activities by aiding senior team members investigating quality incidents and developing CAPA plans.

§Assists and drives process improvement activities as applicable.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

§Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines

§Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures

§Proficiency in PC applications such as word processing, spreadsheets, database management

§Excellent attention to detail, organizational skills, verbal and written communication skills

§Ability to work independently as well as in a team environment

§Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

§Bachelor’s degree in life sciences or other relevant field and 1-year relevant clinical laboratory experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

§Extensive use of keyboard requiring repetitive motion of fingers.

§Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

§Regular sitting for extended periods of time.