Manager Study Start Up

Manager Study Start Up - France - Office

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

We are looking for an Manager, Study Start-Up open to work with our client, a leading pharmaceutical company who are specialised in such therapeutic areas as: Oncology, CAR T-cell, Radioligand, Neurology, Immunology, Rhumatology

The role involves being dedicated to EU-CTR submissions and document preparation.

What You Will Be Doing:
In this role you will be accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with sponsor 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
- 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
- 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 sponsor 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

You will need:

- Solid experience in regulatory preparation and submission under EU-CTR
- 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 sponsor standards
- Solid communication and negotiation skills required.
- Proficient in speaking and writing the country language and English language.
- Good written and oral communication skill

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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 offer