Laboratory Specialist

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

This is a fully office-based role and location of our office is in Bangalore. 

In this position you will be involved in some or all of the following tasks at any given time:

1. Study related activities (Laboratory Support). Manages all laboratory related activities within a clinical study under supervision, including:

• Reviews study documents
• Provides expert advice to PSI and Sponsor study teams
• Contributes to the development of diagnostic strategies, including the development and review of assay validation plans and reports
• Documents and drives the Laboratory Strategy
• Presents laboratory strategy at kick-off meetings
• Supports the selection of central and regional laboratories for studies
• Performs qualification of off-site / on-site laboratories for a study
• Coordinates the contracting of central / regional / off-site laboratories
• Performs central / regional / off-site laboratory set up
• Contributes to Risk Management process
• Provides information to PSI Data Management (DM) to aid eCRF 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
• Provides support / consultancy to Sponsor / PSI team for all laboratory related issues
• Investigates issues with laboratories / couriers / sites
• 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 central / regional off-site laboratories

2. Quality Control & Quality Assurance:

• Develops and/or implements 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

3. Business Development:

• May be required to assist with consultancy in business development tasks

Qualifications

• University or college degree in Life Sciences required
  • An MD degree PhD degree is a plus
• At least 2 years of experience working in a clinical laboratory setting or practical biochemistry/microbiology/cellular biology or medicine company
• Prior clincial research industry experience is a plus
• 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