Senior Clinical Trial Manager - UK/IRE

Job title: Senior Clinical Trial Manager - 14 month assignment (potential to be extended or reassigned within ICON)

Location: United Kingdom - fully remote 

Sponsor dedicated

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

Working fully embedded within an ever expanding program that specializes mainly in the Diabetes space as a CTM, you will be responsible for delivering clinical trials in the shortest possible time in accordance with our clients policies and procedures, SOP’s, local legislation and GCP requirements.

What you will be doing:

• Overall project management of assigned clinical trials 
• Responsible for deliverables and high-quality execution of clinical trials
• Leading trial teams
• Planning, executing, coordinating tasks and communicating between relevant roles, such as CTA and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial
• Attending all trial related meetings / TCs 
• Proactive risk identification and executing mitigation plans
• Ensuring successful start-up of clinical activities (all trial related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure materials for site initiation / selection, e.g. preparing presentations)
• Responsible for trial budgets (ClinCost)
• Execute and follow up on Recruitment and Retention plans 
• Perform Visit Report review (all type of visits)
• Conduct co-monitoring visits 
• CTMS set-up & update at country level
• Oversight and compliance check of STMF (nD/Veeva) 
• Supervise clinical supplies’ processes  e.g. ordering, handling ancillary, import-export process
• Report timely on quality issues
• Audit readiness, audit action plans and follow up for assigned clinical trials 
• Inspection readiness and inspection action plan for assigned clinical trials

To be successful in this role, you must have:

• BA/BS/BSc or RN, with Master level of education preferred
• Fluency in English – written and spoken
• Minimum 5 years of experience in operational aspects of planning and conducting clinical trials
• Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at regional level (e.g. multi country set-up)

• Clinical Development process and procedures
• Project planning experience including oversight of study deliverables, budgets, and timelines
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams (team/matrix environment)
• Knowledge of project risk management assessment and mitigation approaches

• BA/BS/BSc or RN, with Master level of education preferred
• Fluency in English – written and spoken
• Minimum 5 years of experience in operational aspects of planning and conducting clinical trials
• Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at regional level (e.g. multi country set-up)

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.