Global Study Manager (early phase oncology)

IRE • Cary, NC

2d

About The Position

Global Study Manager (hematology/oncology) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What you will be doing: Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance. Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents. Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process. Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data. Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget. Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate. Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report. Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies. Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates. Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget. Support risk management and quality efforts to ensure study compliance. Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness. Prepare presentation material for meetings, newsletters and websites. Support the study team in the implementation of audits and regulatory inspections. Contribute to review of new/amended/unique SOPs and guidance documents.

Requirements

• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Minimum of 3 years clinical trial management experience
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Experience in phase I oncology
• Experience working on a global level
• Candidate must reside in US and work Eastern time (Eastern and Central time zone candidates)
• Experience in external provider oversight and management

Responsibilities

• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• Contribute to review of new/amended/unique SOPs and guidance documents.

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, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees