•Develops the strategy and drives implementation of local tactics for Local Clinical Operations to meet both long-term and annual goals as cascaded from global function(s) or local affiliate.
•Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.
Local Study Management (LMA, PDMA studies):
•Accountable for the execution of all data-generating activities (studies) conducted in the Affiliates, including all Roche sponsored and supported, interventional and non-interventional trials and that execution of these studies is compliant to ICH/GCP & GPP standards, Roche SOPs, local operating guidelines and local requirements including legal and financial standards and practices
Comply with high quality professional standards and Drug safety awareness
•Collaborates, participates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
•University degree or equivalent in a medical/science-related field
•Comprehensive knowledge of ICH GCP, local regulations and all aspects of clinical operational management.
•Clear and accurate communication in written and spoken English. Ability to speak French will be an advantage.
•Familiarity with the therapeutic areas that are priorities for Roche.
•Demonstrated ability to interact with different professional levels of the external clinical research community.
•Extensive experience in clinical trial management.
•Successful track record working in a complex environment, managing multiple tasks and competing priorities simultaneously.
•Demonstrated success working with global/regional/local business colleagues and good understanding of global/local business needs.
•Demonstrated success in setting and delivering departmental goals and managing performance through reliable business indicators.
Successful candidates will meet the following requirements:
Values are what we value: if you are not accountable, brave and creative, please do not apply;
We believe in servant leadership and we only want colleagues with the highest level of ethics;”