Project Manager, Central Labs

About the role

The job sits with a global central labs group that runs lab work for trials sponsored by drug and biotech companies. Success means protocols are set up correctly, documents and contracts stay current, and sponsors feel their studies are in safe hands.

At a glance

What you will do

• Oversee study start-up, turning protocols into a complete and accurate database
• Write study specification documents and keep budgets and contracts in line with them
• Keep a version-controlled master file and confirm sponsors have signed off before any work begins
• Check that lab work follows FDA rules, Good Clinical Practice, IATA and other transport rules
• Act as the main link between sponsors and internal departments through every study phase
• Coach other project managers and suggest ways to improve processes

What they look for

• Experience managing clinical trial projects, ideally with central laboratory work
• Familiarity with FDA regulations, Good Clinical Practice and IATA specimen transport rules
• Confidence presenting lab procedures to investigator sites
• Able to work with IT, data management and lab staff on technical questions
• Legally allowed to work in the US without sponsorship and able to pass a background check and drug screen

A typical week

• Review protocols and consult internal groups on procedures and budget items
• Answer queries from sites and sponsors and resolve day-to-day study issues
• Meet vendors and internal departments to confirm requirements are understood
• Update study documents and contracts as protocol amendments come in