Description
The Regulatory & Start Up Specialist 1, cFSP - Global Support role involves proactively driving and executing start-up and maintenance-related activities and deliverables for assigned studies and sites in Mexico.
Key Responsibilities:
- Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions
- Prepare site regulatory 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 site performance metrics
- Establish and agree on project planning and project timelines
- Inform team members of completion of regulatory and contractual documents for individual sites
- Review, track, and follow up on the progress, approval, and execution of documents
- Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning
- Perform quality control of documents provided by sites
- May have direct contact with sponsors on specific initiatives
Requirements:
- Bachelor's degree in life sciences
- At least 1 year of clinical research experience and study start-up management experience
- Fluent English: written and oral communication skills
- Good analytical and critical thinking skills
- Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility, and adaptability to changing requirements
- Demonstration of successful execution, preferably in start-up, and aptitude for managing multiple priorities in a fast-paced environment