SSO Study Start-Up Manager

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 the country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager(s), SSO Study Start-Up Team Leads, and Clinical Research Medical Advisor as well as the global study team.

Accountabilities:

• Collaborates with SSO Study Start-Up Team Leads, SSO Portfolio Team Leads, Clinical Project Managers, SSU CRA(s) 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 Country Greenlight and last Site Initiation signoff in assigned projects
• Ensures that study start-up activities are conducted and completed on time, including preparation of Key Country Documents, creation and review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for EU CTR submissions, as required
• Coordinates reportable events, milestones and notifications to IEC and Health Authorities via CTIS as applicable
• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
• Ensures adherence to prevailing legislation, ICH/GCP, 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(s) Clinical Research Medical Advisor as well as the global study team
• Leads site selection in collaboration with SSU CRA(s), Clinical Research Medical Advisor and Clinical Project Manager
• Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
• Responsible for “Country Regulatory Greenlight” and ensures all documentation is in place for initial and subsequent drug release.
• 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, and proposing and implementing corrective actions where appropriate
• Leads/chairs local SSU team meetings, and 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

Key performance indicators:

• Performance against study commitments at the country level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (Country approval, Country Greenlight, SIV) and data quality requirements
• Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, EU CTR, IEC, Health Authority and SOP requirements
• Timely submission and delivery of high-quality clinical trial documentation/data

Minimum Requirements:

• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
• Fluent in both written and spoken English, local language as needed
• 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
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

Competencies:

• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

Skills and knowledge:

• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment