Global Study Manager

Clinical Study Specialist - hybrid

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:

• 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.).

• Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.

• 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.

• For outsourced studies, supports GSD/GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant  SOPs and guidelines (e.g. description of services and transfer of obligations).

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

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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