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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. We are currently seeking a Study Manager (CTM) to join our diverse and dynamic team. As a SDM at ICON, you will play a pivotal role in supporting the coordination and management of clinical trials, contributing to the design, analysis, and advancement of innovative treatments and therapies.
Job Responsibility:
Support the coordination and management of clinical trials
Contributing to the design, analysis, and advancement of innovative treatments and therapies
Delivering the clinical study to time, cost and quality
Ensuring inspection readiness by taking an oversight over study eTMF completeness
Working on end-to-end operational study delivery activities, from study setup to study archival
Setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP)
Working cross-functionally, with internal and external partners, on clinical study management activities
Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
Reviewing key clinical documents, including the Protocol and Informed Consent Forms
Leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.)
Facilitating and maintaining interactions and meetings with internal and external partners
Vendor management and CRO oversight, acting as a primary point of contact
Requirements:
Bachelor's degree in a scientific or related field
advanced degree preferred
Minimum of 5 years of experience in clinical research
1-2 years working as an Associate Project Manager within a CRO or Pharma setting
Vendor management experience
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
Well familiar with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard
Strong project management skills (preferably with analytical / financial skills) and good leadership skills
Excellent verbal and written communication in English
Excellent communication and relationship building skills, including external service provider management skills
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments