SSO Study Start-Up Manager

Major 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 / Cluster Head Portfolio, 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, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
• 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 (including subsequent amendments, IBs, DSURs, CSRs)
• Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
• Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
• 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, (proposing and implementing corrective actions where appropriate), 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 Start-up (SSU) CRA, Clinical Project Manager and SSU Lead
• Partners with SSU CRAs to drive all trial level start up activities including essential document collection

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 (IRB/IEC & HA approval, Green Light, SIV) and data quality requirements
• Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Timely submission and delivery of high-quality clinical trial documentation/data

Minimum Requirements:
Work Experience:

• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
• 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
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Thorough understanding of the aspects of drug development, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations
• Experience and understanding of drug importation aspects an advantage

Skills:

• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment
• Effective time management
• Regulatory Compliance.

Languages :

• English.