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

What you will be doing:

• Support or oversee the execution of select complex study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
• Oversee Strategic Partners and/or other CROs and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
• Accountable for planning and operational strategy and execution for assigned clinical trials o Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
• Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
• Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs
• In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
• Support data review for database lock and CSR writing and review (including appendices)
• Collect/review/File study documents in support of the trial master file (TMF)
• Collect/review/File study documents in support of the regulatory filing
• Responsible for overseeing study financial reconciliation
• Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
• Site relationship management
• Review and provide oversight of trial audits
• Proper and timely follow up to audit findings and CAPAs
• Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations

You are:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
• Demonstrated successful experience in project/program management and matrix leadership o E.g. timeline/budget management o E.g. Risk identification and management
• Works independently and is highly organized
• Good communication skills
• Excellent teamwork, organizational, interpersonal, and problem-solving skills, including successful experience with Leading cross-functional teams, vendor selection and oversight
• Demonstrated successful experience managing recruitment challenges and boosting enrollment  Fluent business English (oral and written)

• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA).  Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. 

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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.