Regulatory and Start Up Manager - Israel

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.
• 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.
• In satellite countries 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 ensure all documentations is in place for initial and subsequent drug release.
• Responsible for review and sign off of 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 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.