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.
To provide scientific support to Clinical Trials Clients and Laboratory Staff in North America
- Support presentations to clients and client visits
- Develop and validate new analytical methods required for the clinical trials laboratory.
- Write validation plans and reports for analytical methods.
- Work with Laboratory staff to ensure smooth method set-up and transfer for routine use.
- Develop a good understanding of the business and build relationships with Clinical Scientists at other sites
- Assist in responding to client and Clinical Trials staff on technical requests. Technical requests may include: Principles of laboratory tests, details on sample requirements, testing location, cost of testing and result interpretation.
- Support in the interpretation of Laboratory data from clients studies & review for trends
- Work with colleagues on ensuring standardization of methods and reagents at all sites.
- If required act as a principal investigator for Companion Diagnostic or In Vitro Diagnostic studies. This includes ensuring compliance with all applicable regulations and sponsor study requirements.
- All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of clinical testing procedures and applicable laboratory testing regulations
- Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
- Knowledge of occupational safety and health rules and regulations
- Excellent written and oral communication skills
- Excellent client management and problem resolution skills
- High ethical standards
- Ability to assess and prioritize multiple tasks, projects and demands
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- PhD in a clinical science related subject highly preferred or a BS/MS in a clinical science related subject plus 5 years post qualification experience; or equivalent combination of education, training and experience in bioanalytical laboratory environment
- The post qualification experience should be in a clinical laboratory, pharmaceutical, academic or laboratory diagnostic manufacturer area. Experience with assay development in one of these areas is preferred.
- Familiarity with Laboratory QC / QA and laboratory Statistics, as well as Laboratory Accreditation Schemes and External Proficiency Testing.
- Ability to accept assignments and work independently with follow-up to project completion. Formal project management training preferred.
- Excellent Communication (interpersonal, verbal, written, and presentation) skills.
- Excellent computer literacy required (Microsoft Office, Word, Access, and Excel).
- Ability to research new projects through Literature searches using library and Internet.
- Knowledge and / or experience of Pharmaceutical Drug development process and conduct of clinical trials preferred
- Knowledge of Pharmaceutical / Diagnostic Industry regulations for Analytical Method Validation and verification.
- Ability to write concise project plans and final reports.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
EEO Minorities/Females/Protected Veterans/Disabled
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 firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1065250