This job is no longer available
Leica Biosystems - We‘re Hiring in Massachusetts!
Leica Biosystems is one of the fastest growing diagnostics companies in the world. Our rapid growth in companion, immunohistochemistry cancer diagnostics and pharmacuetical partnerships, requires the addition of energetic and knowledgable scientists to our development and commercial teams.
We're recruiting a Clinical Operations Manager who will have manage external validation activities for the co-ordination of external clinical trials for all products and the supporting of the launch of cancer diagnostic tests.
The successful applicant will:
Proactively establish strong relationships with external service providers, including reference laboratories and sample repositories to ensure access to required samples and infrastructure required to efficiently run a given study. This includes establishing relationships different geographic regions in line with planned launches of Companion Diagnostic tests.
Prepare clinical trial documentation including sampling needs to enable Biomarker and Diagnostic assay development and validation.
Manage and process data sets emerging from clinical trials.
For companion diagnostics development projects, work closely with Pharma Partnerships team and respective CROs for input to the development of an optimal Clinical Development Plan together with Pharma collaboration partners.
Ensure consistency of and adherence to global clinical standards. Prepare and implement additional quality documents as required (SOPs, work instructions, guidelines and policies).
Mentor and coach to develop personnel on the team and within the function.
Manage, monitor and promote continuous improvement activities through the use and implementation of management tools to ensure processes are evaluated constantly for effectiveness