Manager of Study Start Up

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

What you will be doing:

• Accountable for site Start-Up for 2 or more clinical studies.
• Serves as primary point of contact (POC) and escalation for Site Start-Up on assigned clinical studies.
• Holds Start-Up Kick Off Meeting with Manager, Study Start-Up, European Union (EU), Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders.
• Holds weekly Start-Up meetings with Manager, SSU, EU, PL, CCM, Legal, and other key stakeholders as necessary.
• Forecasts and tracks progress of Site Start-Up, ensuring all sites on assigned clinical trials are greenlit on time per study Start-Up timelines.
• Escalates site issues to appropriate Clinical Study Team members.
• Attends Clinical Study Team Meetings through Start-Up.
• Prepares and updates Start-Up packets for clinical studies.
• Assigns sites to Study Start-Up Specialists, manages Study Start-Up Specialist and Study Start-Up Assistant workload for assigned studies.
• Ensures Study Start-Up Specialists collect, review, and track essential documents, and review Informed Consent Form (ICFs) in accordance with Client processes and timelines.
• Responsible for reviewing greenlight packets and greenlighting sites.
• Ensures Study Start-Up Team members are properly trained on site Start-Up activities and kept current on timelines, contract and budget status, and study updates for assigned clinical studies.
• May be responsible for sending Start-Up packets, reviewing ICFs, collecting essential documents, and helping sites with ethics committee submissions for one or more clinical sites.

You are:

• Minimum of 5-8 years of relevant clinical trial experience.
• Minimum of 2-4 years clinical trial management or equivalent Start-Up unit management experience.
• Thorough knowledge of clinical Start-Up process and requirements required.
• Thorough knowledge of CFR and ICH/GCP requirements is required.
• Requires effective organizational and time management skills.
• Able to multi-task under limited direction and on own initiative.
• Strong communication and inter-personal skills.
• Ability to coordinate work cross-functionally with diverse teams.
• Highly responsive and proactive, a team player.
• Previous Start-Up unit experience, preferred.
• Experience managing large teams (direct or dotted line reporting), preferred.
• Oncology clinical research experience, preferred.
• Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.

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.