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The Country Site Activation team is dedicated to identifying and activating sites to the highest quality, ensuring patients on clinical trials have access to safe and effective medication. As a Regulatory Services Imports Specialist, you will perform tasks at a country level associated with Study Start Up contracts, developing the global contracting strategy and supporting the delivery of all required start-up contracting activities as determined by client requirements.
Key Responsibilities:- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary, ensuring adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation import activities according to applicable regulations, SOPs, and work instructions, distributing completed documents to sites and internal project team members.
- Prepare site import documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on imports performance metrics.
- Review, establish, and agree on project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.
- Inform team members of completion of regulatory and contractual import documents for individual sites.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- Minimal requirements:
- Bachelor's Degree in Life Science or related field.
- At least 1-2 years of experience in Regulatory and Start-up Imports area or similar (or equivalent combination of education, training, and clinical, healthcare, and/or pharma experience).
- Fluent language capabilities, including English.
- Consistent career growth.
- Leaders that support flexible work schedules.
- Programs to help you build your therapeutic knowledge.
- Dynamic work environment that exposes you to new experiences.
- Attractive benefits package.
- Home-based role.
- Grade 140 (Sr. role).