Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
Contributes to the planning and conduct of internal and external meetings (e.g.
Investigators'/Monitors' meeting).
Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Ensures that all study documents in scope of GSM's responsibilities are complete and verified for quality in Trial Master File.
Supports GSD/GSAD with budget management, such as external service provider invoice reconciliation.
Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
Supports GSADs in project management as per agreed delegation.
Your profile:
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Experience in global study management focused heavily on the management of vendors and external partners
Knowledge of clinical development / drug development process in various phases of development and therapy areas
Excellent knowledge of international guidelines ICH/GCP
Excellent communication and relationship building skills, including external service provider management skills
Good project management skills
Demonstrated ability to collaborate as well as work independently
Demonstrated leadership skills
Computer proficiency, advanced computer skills in day-to-day tasks
Excellent verbal and written communication in English
Early phase oncology experience required
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .
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Benefits
Health insuranceDental insuranceVision insurance
Additional Information
Global Study Manager - early oncology
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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