Responsible for operational set-up & follow-up of clinical laboratory related activities to guarantee alignment among the entire network to support delivery of clinical results timely at right quality and cost
The laboratory network is
- Client Laboratories in charge of development, validation and/or routine of drug response assays
- Central laboratories in charge of global laboratory support to clinical studies such as sampling material delivery, sample handling and management as well as testing (e.g. subject’s safety parameter evaluation).
- Research laboratories in charge of development and/or validation of new drug response assays as well as inter-laboratory method transfer.
- Global operational point of contact for all client stakeholders and contracted central laboratory study representative to coordinate any laboratory related activities of clinical studies (phase I to IV) in standard and complex operational or regulatory environments
- Co-ordinate all project related activities.
- Responsible for planning, implementing and reviewing a project including technical, timing, resourcing and financial aspects of the project.
- Manage the project team on a daily basis.
Duties and responsibilities
- Ensure effective interface between Client Clinical Laboratories and Clinical Project Team, especially Global client Project Manager, by providing input in study protocol, laboratory instructions for investigator sites, informing about testing due dates, sample management or testing issues.
- Be the Clinical Project Team voice within global client Clinical Laboratories to communicate needs and constraints in terms of sample management & laboratory support.
- At study level, pro-actively coordinate set-up & follow-up of operational laboratory related activities :
- Communicate study needs and timelines in a cohesive manner to all appropriate client stakeholders. Acts as the global point of contact for study sample management and laboratory status, negotiate due dates
- Ensure daily deliverables and study milestones are respected, define and analyze KPIs, identify trends and ensure problems are addressed
- Identify necessary process improvement to ensure both sample management & laboratory output meet client company standards, GCP-ICH /GCLP as well as project requirements
- Ensure follow-up of budget is done to highlight any deviation from initially agreed budget/contract.
- Liaison between sponsor and project team for technical, timeline, quality and contractual aspects.
- Set up and plan the project activities in collaboration with the project team
- Plan for and review resourcing, timing, project quality and project budget.