Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you will play a key role in the management, preparation, review, and coordination of Country Submissions in alignment with the global submission strategy. In addition, you will support critical study start-up activities, including coordination with sites on agreements and budgets to ensure timely site activation. As a Country Approval Specialist, you will ensure submissions and start-up activities are executed efficiently and aligned with both regulatory requirements and study timelines.
What You'll Do:
- Prepares, reviews, and coordinates, under guidance, local regulatory submissions (MoH, EC, and other applicable national requirements) in alignment with global submission strategy
- Provides, under guidance, local regulatory strategy advice (MoH and/or EC) to internal stakeholders
- Acts as a key country-level contact for ethical and regulatory submission-related activities
- Coordinates with internal functional departments to align submission activities with site start-up timelines and study milestones
- Supports site start-up activities, including coordination of site agreements, budgets, and payment schedules to facilitate timely site activation
- Assists in reviewing and coordinating site contract and budget-related documents, working closely with internal stakeholders and sites
- May engage with investigators and site personnel for submission and start-up related activities
- Supports feasibility activities and ensures alignment with study timelines
- Ensures accurate and timely entry and maintenance of study information in tracking systems
- Prepares, maintains, and ensures compliance of local study files in accordance with SOPs and client requirements
- Maintains up-to-date knowledge of applicable SOPs, regulatory requirements, and guidelines
Education and Experience Requirements:
- Bachelor's degree or equivalent in a relevant field
- Minimum 3+ years of experience in clinical research, regulatory, or study start-up roles
- Experience supporting site start-up activities, including site agreement and budget coordination, is preferred
- Equivalent combination of education, training, and experience will be considered .
Knowledge, Skills and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal and stakeholder management skills
- Strong attention to detail and quality of documentation
- Good negotiation skills, particularly in supporting site agreements and budget discussions
- Basic understanding of clinical trial start-up processes, including regulatory submissions and site activation activities
- Ability to coordinate across multiple stakeholders and timelines
- Good computer skills and ability to learn relevant systems
- Good English language and grammar skills
- Basic knowledge of medical terminology and therapeutic areas
- Ability to work independently and within a team environment
- Basic knowledge of applicable regional and local regulatory requirements
Working Conditions and Environment:
- Work is performed in a flexible (hybrid) environment, with occasional on-site presence at the client's office may be needed.
