Lead Site Activation Manager

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

What you will be doing:

• Responsible for activation of all study sites to meet project timelines
• Responsible for oversight of SAMs assigned to trial
• Interaction with other departments to communicate and negotiate timelines , including Clinical Budget Management and Regulatory Affairs
• Facilitate Informed Consent Form review and negotiation process for study, country and site templates
• Effectively communicates project risk and mitigation strategies to Study Team members
• Lead problem solving and resolution efforts to include management of risk, contingencies, and issues
• Identify quality issues within the study to implement appropriate corrective action plans.
• Facilitate generation and finalization of documents and applicable translations for global regulatory and EC submissions according to applicable SOPs and WIs
• Ensures data integrity by overseeing data cleaning efforts for internal information systems, setting standards for data entry and maintenance
• Mentors and coaches junior staff as assigned
• Performs other duties as assigned

You are:

• Organizational skills to independently manage all aspects of study activation and meet project deadlines
• Experience and expertise in managing high‐volume clinical study start‐up activities
• Strong understanding of global study start‐up requirements and activities, including Informed Consent Form requirements
• Excellent communication (written and verbal) skills to be able to interact with internal groups (Legal, Medical Monitors, Regulatory Affairs, etc.) as well as external groups (e.g. Investigators and CRO, if applicable)
• Able to proactively identify project opportunities, challenges, risks and implement appropriate actions with minimal supervision
• Ability to work in a matrix, cross‐functional team
• Demonstrates thorough knowledge and understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP’s governing the start‐up of clinical trials
• B.S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager) and minimum of 10 years of relevant work experience

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/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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