Evidence Delivery Specialist

ICON plc • Montreal, QC

5d

About The Position

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.

Requirements

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience
• Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
• Excellent written and verbal communication skills as well as proven collaboration and influencing skills
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Demonstrated ability to collaborate as well as work independently
• Ability to effectively work with Clinical Research Organizations/External Providers

Nice To Haves

• Preferred background in medical affairs/investigator initiated studies
• Proven ability to interact widely and effectively within the company across regions, functions and culture
• Ability to manage competing priorities

Responsibilities

• Executes activities to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including Maintain Study Inspection Readiness Tools
• Coordinate and oversee periodic study-level TMF/Master File (MF) QC
• Perform Periodic TMF/MF QC on behalf of Study/EAP Management
• Customization of the study’s Expected Document List (EDL) in collaboration with the CROs
• Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
• Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained
• Ensure handover documents are created, signed and filed in TMF
• In collaboration with CRO, support creation, execution and maintenance of TMF/MF Plan
• Supports key study start-up activities, in collaboration with CRO and internal functions as needed
• Support compliance and quality deliverables
• Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums
• Support budget management activities including

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: Mid Level