The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in Denmark
Job Summary
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in Denmark.
Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable, and prepares and finalizes local submission packages.
Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution according to Novartis standards and local and international regulations.
Matching Summary
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in Denmark.
Skills & Requirements
Must-have
Study planning and activation deliverables
GCP/ICH and regulatory compliance
Collaboration with global study team
Timely start-up activities
IRB/IEC and Health Authority submissions
TMF document quality and accuracy
Nice-to-have
Innovative and efficient process implementation
Leadership in a matrix environment
Quality and compliance issue resolution
Site initiation and patient enrolment planning
Key Requirements
Minimum 5 years clinical operations experience
Degree in scientific or health discipline
Advanced degree with clinical trial experience preferable