Manager Study Start-up

The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with client´s 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 back-up and deputy of the country manager.

• 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 client´s 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´s 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

Activities & Interfaces:

• Interfaces with global trial execution organization in support of Country SSU Lead to Global SSU managers for all portfolio deliverables as needed.

• Partners with SSU CRAs to drive all trial level start up activities including essential document collection.  Key Performance Indicators:

1. 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
2. Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

1. Timely submission and delivery of high-quality clinical trial documentation/data

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What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.