Global Client / Great Career Opportunity / Negotiable Salary & Bonus Package
About the job
Purpose
Breakthroughs that change patients' lives... Our client is a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Summary
The Director of Clinical Site Operations (DCSO) is accountable for ensuring appropriate Site Relationship Partner/Site Relationship & Excellence Partner (as applicable), as well as Country Trials Manager resources are in place to deliver on study and site-level start-up activities in-line with study milestones in the designated countries/clusters/regions.
The DCSO is also accountable to ensure operational site management and oversight activities within a designated country/cluster/region. This role is also accountable for the Site Excellence Partner remit within their assigned country/cluster/region and supervises the compliance oversight activities to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Company standards.
This is a strategic role that coordinates cross functionally with others in Study Start Up, Study Optimization, and Study Management to provide input to country and site selection and to execute investigator site strategies and site-level start-up activities. The Director of Clinical Site Operations represents Global Product Development (GPD) as the in-country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across a portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy. This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders.
Applicable to certain countries/countries/regions, the role also is accountable for therapeutic area/asset/study-level activities, working in coordination with other key GPD roles, including but not limited to, Directors of Study Management and Clinical Study Team Leaders. The Director of Clinical Site Operations leads initiatives that support the clinical development environment within their country/cluster/region to facilitate clinical development goals and scientific leadership. For example, this role actively manages threats to, or identifies opportunities for, clinical trial conduct through engagement with local clinical development leaders, institutions/networks, and/or regulatory authorities.
The Director of Clinical Site Operations provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the study and site level) on the trial’s conduct.
The Director of Clinical Site Operations will contribute to and implement strategic initiatives as a representative of the GSSO Leadership.