Global Study Manager

Global Pharma seeks Global Study Manager in Early Hematology/ Permanent/ Home-based

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 Senior Clinical Trial Manager (Global Study Manager) to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities.

What you will be doing:

- Recognize, exemplify and adhere to ICON's values which center on our commitment to people. Clients and Performance.
- As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs. Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.
- Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
- 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.

Your profile:

- University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
- Minimum of 3-4 years of progressive clinical trial experience
- Must have global experience
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Early Phase experience
- Hematology experience is desirable
- Excellent knowledge of ICH-GCP principles
- Team orientated
- Ability to coordinate and prioritise multiple tasks and deliverables
- Proactive approach
- High degree of flexibility Demonstrated verbal and written communication skills
- Good negotiation and collaboration skills
- Demonstrated interpersonal and problem
- solving skills
- Some travel may be required

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-bei