Description
The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
- Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
- Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
- Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
- Provide input to data management documents (e. g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
- Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
- Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
- Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
- Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
- Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
- Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
- Support risk management and quality efforts to ensure study compliance.
- Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
- Prepare presentation material for meetings, newsletters and websites.
- Support the study team in the implementation of audits and regulatory inspections.
- Contribute to review of new/amended/unique SOPs and guidance documents.
- University degree / Bachelor's degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
- Minimum of 3 years clinical trial management experience
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Experience in phase I oncology trial oversight
- Experience working on a global level
- Some travel may be required
**Why ICON?**
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Compensation Information:
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