[Remote] Project Manager

Note: The job is a remote job and is open to candidates in USA. ICON plc is a world-leading healthcare intelligence and clinical research organization. The Global Study Lead - Oncology role is responsible for planning and leading the delivery of oncology studies, ensuring compliance with guidelines, and managing study budgets and vendor oversight.

Responsibilities

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and sponsor SOPs, for all products and services delivered for their designated studies
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
• Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation
• Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development
• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary
• Identify and communicate resource gaps for assigned studies
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
• Lead / contribute to ways of working and process improvement initiatives. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with Oncology aligned staff in global functions to deliver the Clinical Study Report
• Work with the Oncology patient councils to develop patient centric documents and address patient burden

Skills

• Bachelor's degree in life sciences or related discipline
• Extensive clinical development experience that is equivalent to 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment
• Proven operational experience leading global oncology clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget
• Proven leadership skills, influencing and negotiation skills
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change
• Oncology phase III global registrational study leadership experience
• Proven clinical development experience across all phases of development (I-IV)
• Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralized trials (DCT) initiatives
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
• Creative thinker able to modernize approach to clinical delivery, leverage externally

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Company Overview

Company H1B Sponsorship