SSO Study Start-up Manager
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Description 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. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. Act as primary back-up and deputy of the country manager.Job Description
Accountabilities:
Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead SSO Country Head Portfolio / SSO Cluster Head Portfolio
Collaborates with SSO Country / SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
Ensures close collaboration with local IRBs/IECs and Health Authorities as applicable
Ensures that study start-up activities are conducted and completed on time including preparation of IRB/IEC submission packages and review of Informed Consent Forms
Prepares and finalizes local submission package for submission to IRB/IEC CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable
Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
Accountable for timelines accuracy and quality of country TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with Novartis strategy
Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team
Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned
Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase escalating as necessary
Ensures sites are prepared for Green Light and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site Green Light
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
Leads/chairs local SSU team meetings in assigned studies participates in global study team meetings as required
Leads the development of country site initiation and patient enrolment plans together with SSU CRA CPM and SSU Lead
Education:
A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management is preferable
Languages:
Fluent in both written and spoken English local language as needed
Experience/Professional requirement:
Minimum 5 years experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment without direct reports
Skills Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall ModelRequired Experience:
Manager
Key Skills
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
