Study Start-Up Manager

ICON plc • Blue Bell, SD

21h

About The Position

Study Start-Up Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with client 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 Feasibility Manager and Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager. What you will be doing: Supports country SSU strategy in close collaboration with Study Start-Up Team Lead, Country Head Portfolio / Cluster Head Portfolio Collaborates with Country / Cluster Head Portfolio, 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 client 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 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 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 client 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

Requirements

• 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 international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and client standards
• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment

Responsibilities

• Supports country SSU strategy in close collaboration with Study Start-Up Team Lead, Country Head Portfolio / Cluster Head Portfolio
• Collaborates with Country / Cluster Head Portfolio, 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 client 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
• 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 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 client 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

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed