Clinical Study Manager Ii

2 maanden geleden

Groningen, Nederland Icon plc Voltijd

Clinical Study Manager
- Phase I Research

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

The Clinical Study Manager II provides clinical trial management for in-house and outsourced studies, performs quality checks, protocol and document
development, and executes study delivery plans aligned with program goals and timelines. Based at ICON's Early Phase Clinic in Groningen, Netherlands.

What you will be doing
- Reviews and assesses the research protocol, clinic budget, case report forms, informed consent forms and study volunteer information.
- Participates in the assessment, preparation and implementation of studies for the clinic to ensure a timely and high-quality study output.
- Conducts feasibility analysis. Reviews availability and workload for study volunteers, practicability and required personnel. Creates risk analysis and contingency plans. Coordinates in
- and outpatient visits.
- Serves as liaison between all clinic groups and the applicable clinic management. Communicates any changes in scope and/or cost and escalates issues and/or major deviations. Serves as clinic contact for the study sponsor.
- Prepares and reviews clinic documents.
- Ensures proper sampling, collection and transmission of research data samples.
- Communicates any changes in scope and/or cost and escalates issues and/or major deviations. Serves as clinic contact for the study sponsor.
- Monitors the study timelines and output by clinic staff according to protocol and internal procedures.

Your profile- Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.- Previous experience in clinical research, preferably within the CRO or pharmaceutical industry.- Understanding of clinical trial regulations, guidelines, and industry standards.- Excellent leadership and communication skills, with the ability to effectively manage cross-functional teams.- Strategic thinking and problem-solving abilities with a focus on driving results.

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 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. Visit our

careers site

to read more about the benefits ICON offers.- here
- .

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