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Regional Trial Initiation Director
2 months ago
Job Title: Regional Trial Initiation Director
We are seeking a highly motivated Regional Trial Initiation Director to oversee and execute the review, negotiation, and approval of site budgets and payments on a regional and global scale. This role will play a pivotal part in driving process improvement initiatives and ensuring compliance with industry standards.
Key Responsibilities:
- Oversee the review, escalation, negotiation, and approval of site budgets and payments
- Lead or participate in regional and global improvement projects related to Study Start Up and other processes involving budgeting and payments
- Develop and execute country-specific budget and payment process documents
- Conduct regular regional trend analyses and provide support and training to ensure understanding of budgeting and payment processes
- Collaborate with Country Operations and act as a liaison with Global Site Budgets and Payments
Required Qualifications:
- Bachelor's degree in a scientific discipline; MBA or advanced degree preferred
- Minimum of 5 years of clinical research experience in the pharmaceutical/biotech industry
- Strong understanding of Fair Market Value principles and knowledge of Standard of Care/Routine Care
- Excellent communication, presentation, and change management skills
- Proficiency in GCP/ICH and applicable regulatory guidelines
- Strong organization and prioritization skills
Preferred Qualifications:
- Business acumen and/or financial background, especially in Investigator grants and payments
- Experience managing external relationships with CROs, academic collaborations, and strategic partnerships
- Knowledge of medical billing and coding
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):