SSO Study Start-Up Manager

Job Description Summary

The SSO Study StartUp 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 a standalone country OPC (operating country) or satellite country. 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. In satellite countries acts as primary backup and deputy of the country manager.

Job Description

Major accountabilities:

• Supports country SSU strategy in close collaboration with SSO Study StartUp 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 startup 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 startup 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 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 startup 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.
• Supports 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 startup 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 SSU CRA CPM and SSU Lead

Key performance indicators:

1. Performance against study commitments at the country level (actual vs. planned patients) including setup/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval Green Light SIV) and data quality requirements
2. Delivery of study milestones in adherence to prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements
3. Timely submission and delivery of highquality 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 setup execution and monitoring
• 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 (SFDA) regulations and Novartis standards

Skills:

• Clinical Monitoring.
• Clinical Research.
• Clinical Trial Protocol.
• Clinical Trials.
• Decision Making Skills.
• Drug Development.
• Health Sciences.
• Lifesciences.
• Regulatory Compliance.
• Strong interpersonal negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment

Languages :

• Fluent in both written and spoken English local language as needed

Skills Desired

Clinical Monitoring Clinical Research Clinical Trial Protocol Clinical Trials Decision Making Skills Drug Development Health Sciences Lifesciences Regulatory Compliance

Required Experience:

Manager