Study Start Up Manager - UK based

Job title: Study Start Up Manager 

Location: UK (fully homebased)

Fully sponsor dedicated

As a Study Start Up Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with our clients 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. 

What you will be doing:

• 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 our clients 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

To be successful, you will need to have the following:

• 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 our clients standards
• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, 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.

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.