Regulatory and Start Up Specialist
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Job Description
Regulatory Specialist managing Site Activation for clinical studies in life sciences. Ensuring compliance with regulations and quality in deliverables for Swedish sites.
Responsibilities:
- Perform tasks associated with Site Activation (SA) activities
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
- Ensure adherence to standard operating procedures (SOPs), quality of designated deliverables and project timelines
- Perform start up and site activation activities according to applicable regulations
- Distribute completed documents to sites and internal project team members
- Prepare site regulatory documents, reviewing for completeness and accuracy
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Implement contingency plan as needed
- Inform team members of completion of regulatory and contractual documents
- Review, track and follow up the progress, the approval and execution of documents
- Provide local expertise to SAMs and project team during initial and ongoing project timeline planning
- Perform quality control of documents provided by sites
Requirements:
- Bachelor’s Degree in life sciences or a related field
- 3 years’ clinical research or other relevant experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Local Swedish fluency
- In country (Swedish) submissions experience required
- Biobank experience is a must
- Contracts experience is a benefit
Benefits:
- Health insurance
- Professional development opportunities
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