Program Manager

As a Global Trial Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This is a permanent and home-based role, full-time employed by ICON and sponsor dedicated to our client. The role will be working within the Early Development portfolio of studies. 

What you will be doing:

• Leads the cross-functional Trial Team; tracking of project deliverables and timelines using functional planning tools and support.
• Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
• Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines. Responsible to drive the final study placement and ensures alignment with and communication to the involved stakeholders, including TA and feasibility leads.
• Develops the trial ESP strategy for assigned trial(s) in line with the overall program ESP strategy.
• Is accountable for oversight of all external service providers for both inhouse and outsourced studies.Is responsible for vendor selection and set up, including scope of work and specifications in line with protocol requirements, budget and timelines.
• During execution, the GTL will ensure escalated vendor issues are appropriately resolved. For outsourced trials is responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
• Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operate in a constant state of inspection-readiness.
• Collaborate with Bioresearch Quality and Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they can’t be resolved within the function and/or Trial Team they are escalated to the GPL and Clinical Team level, as necessary.
• Manages timely and accurate documentation of issue escalation. Drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.

You are: 

• Bachelor’s degree or equivalent, preferably in Life Sciences.
• Minimum of 8 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experienced and proven track record of success in managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management.
• Excellent leadership skills and proven ability to foster team productivity and cohesiveness. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision. Experience with mentoring/coaching others.
• Specific therapeutic area experience ideally in Gene Cell Therapy and Early development.

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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