Ref #: 26463

Employment type: Permanent - Full-Time

Location: Ireland

Posted: 01-Feb-2021

Description

JOB FUNCTIONS/RESPONSIBILITIES

•Serve as Technical expert to CST for vendor selection, budget and timeline estimates
•Translate the protocol requirements into vendor technical specifications; liaise with procurement for vendor proposal, budget and contract
•Review and finalize vendor plans, manuals and tools. Oversee UAT completion. Ensure finalization of vendor requirements on time
•Monitor the collection, processing and analysis of data. Evaluate vendor compliance and data quality, manage budget revisions throughout study
•Serve as primary point of contact for vendor issues escalation. Track corrective actions in relation to issues and audit findings
•Provide analysis and reporting of cross-project trends, issues and risks
•Develop tools, processes and reports which simplify and standardize CST/ vendor interface

Knowledge
•Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
•Ability to build new relationships and to interact with Providers. Enhance the communication with the Trial Operations Study team and with the different Vendors
•Scientific/Technical Excellence
•Clinical Development process and procedures
•Project management experience including oversight of study deliverables, budgets, and timelines
•Experience anticipating and resolving problems
•Experience writing and presenting clearly on scientific and clinical issues
•Experience collaborating and leading cross-functional teams (team/matrix environment)

Basic qualifications
•Master’s Degree - OR
•Bachelor’s Degree and 2 years directly related experience - OR
•Associate’s Degree and 6 years directly related experience

Preferred qualifications
•BA/BS/BSc in the sciences or RN
•7 years work experience in life sciences or medically related field
•Broad experience working in life sciences or medically related field, including general clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
•Experience working in Clinical Research Vendors (CROs, central labs, imaging vendors, eCoA etc.)