Accountable for execution and oversight of local operational clinical trial activities
Ownership of country and site budgets
Development, negotiation, and execution of Clinical Trial Research Agreements (CTRA)
Oversight and tracking of clinical research-related payments
Payment reconciliation at study close-out
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols
Works in partnership with IRB/IEC and Regulatory Authority
Responsible for managing country deliverables, timelines, and results for assigned protocols
Contributes to the development of local SOPs
Works in close collaboration internally and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
Oversight and coordination of local processes and SOPs

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution
A minimum of four (4) or more years of relevant Start-up clinical research experience in pharmaceutical or CRO industries
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements
Excellent communication skills, oral and written
Self-motivation with the ability to work under pressure to meet deadlines
Detail and process oriented
Ability to lead and develop junior staff
Problem solving and Process Improvement is essential to this position
Minimum of eight (8) years of clinical research experience

Project Manager

Key skills