Study Delivery Lead - Home- Based (US)

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

This position within GCD is accountable end to end from CSI (Commit to Study Initiation) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.

What you will be doing:

• Have accountability for the operational delivery of clinical study to time, quality, and budget (e.g., country selection, patient diversity, patient engagement strategy, recruitment plan, etc), driving decision-making at pace and leading study team to achieve overall study deliverables.
• Accountable for assessment and selection of other study vendors under GCD responsibility.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs for assigned studies. understand study contribution to program/submission.
• Accountable for translating asset requirements to the study and appropriate communication with the Asset Lead.
• Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
• Proactively and effectively identify, oversee, and mitigate study risks.
• Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
• Preparation of materials for governance and / or financial review cycles.
• Accountable for the study budget.
• Effectively build and lead empowered matrix teams. Not required to line manage staff.
• Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions.
• Decision maker for the innovative solutions (eg DCT) to be used at study level.
• Responsible for operational input into protocol and informed consent form development, and other key study documents.
• Lead and conduct investigator meetings and other study related meetings; participate in governance meetings as required.
• Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
• Ensure data quality plans and end to end data cleaning is performed instream by the responsible line functions.
• Ensure Clinical Study Report is delivered on time and supports adherence to local regulatory guidance.
• Identify and communicate resource gaps for assigned studies.
• Lead / contribute to ways of working and process improvement initiatives.

You are an individual with the following:

• Education Requirements (minimum expected):
  • Bachelor’s degree: life sciences or related discipline
  • The role will require a good understanding of complex clinical development and regulatory processes.

• Job Related Experience (minimum requirements):
  • Experience in clinical research: study management, monitoring, data management.
  • Strong skills and experience in project management and tools.
  • In depth knowledge of GCPs and ICH guidelines.

• Other Job-Related Skills:
  • Solid experience working in teams with a broad range of cultures, including matrix team leadership (not required to line manage staff).
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
  • Excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs.
  • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
  • Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
  • Able to set and manage priorities, performance targets and project initiatives in a global environment.
  • Operational expertise in risk management and contingency planning.
  • Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency.
  • Demonstrates conceptual, analytical and strategic thinking.
  • Effective at problem solving and conflict resolution.
  • Ability to manage change and uncertainty.
  • Ability to delegate tasks.
  • Demonstrate experience in multicultural settings (to reflect our external customers / clients / health authorities / patients and diverse environments with respect to dynamics of human interaction (including working with remote teams)

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.