Top 3 Must Have Skill Sets:
Clinical trial management experience
Operational performance experience
Project planning experience
Day to Day Responsibilities:
Develop and maintain knowledge of external local clinical trial environment and assess impact on study design and execution
Develop and maintain repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas
Understand patient flows and referral pathways in support of global/local operational delivery
Partner with OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
Select the sites (support selection for sites in Early Development studies) within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process.
Identify and contract Reference Sites in support of local landscaping
Engage with local reference sites in collaboration with local medical team to obtain input on proposed study design (Study Design Optimization) and partner with OFSMs and GCPM representatives to analyse local feedback for incorporation into study design and operational planning decisions
Support operating reviews by analysing COLA participation and outcomes, predictability and delivery Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager Forum
Act, on request, as DFM – POC, coordinating and analyzing the COLA outputs and sharing these with GCPM
"This posting is for Contingent Worker, not an FTE"