Laboratory Specialist
About The Position
PSI is a dynamic, global company founded in 1995, comprising over 3000 dedicated individuals. The company operates at the forefront of medical science, aiming to improve lives and deliver new medicines to those in need. The Laboratory Specialist role involves managing all laboratory-related activities within clinical studies under supervision. This includes providing expert advice to study teams, contributing to diagnostic strategies, and overseeing the selection, contracting, and setup of laboratory vendors. The specialist is also responsible for quality control and assurance, participating in the development and implementation of operational quality control documents, and engaging in system audits related to laboratories.
Requirements
- University or college degree in Life Sciences
- An MD degree
- At least 2 years' experience working in a clinical laboratory setting
- Strong communication and presentation skills
- Attention to detail and organizational skills are critical
- Ability to work in a team setting as well as independently as needed
- Proficient in using Microsoft Office tools
Nice To Haves
- PhD degree
- Prior clinical research industry experience
Responsibilities
- Manages all laboratory related activities within a clinical study under supervision
- Reviews laboratory-related study documents
- Provides laboratory-related advice to PSI and Sponsor study teams
- Contributes to the development of diagnostic strategies
- Presents laboratory strategy at kick-off meetings
- Supports the selection for studies
- Performs assessments of off-site / on-site laboratories for a study
- Coordinates the contracting of laboratory vendors
- Performs set up of laboratory vendors
- Contributes to Risk Management process
- Provides information to PSI Data Management (DM) to aid clinical trial database design
- Delivers training to the study team and/or clinical sites in laboratory related procedures
- Performs initiation and monitoring visits to laboratories as required
- Coordinates routine calls with central laboratories
- Attends study progress calls with the Sponsor
- Investigates issues with laboratories
- Coordinates the transfer of samples between laboratories
- Assists DM in on-going data reconciliation
- Coordinates any changes to the laboratory strategy
- Performs close out of laboratories
- Participates in the development and/or implementation of operational (project specific and laboratory specific) quality control documents
- Participates in system audits and follows up on audit findings related to laboratories that provide testing for the assigned projects
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
