Payer Compliance Specialist
Expressable
Global Study Manager - Oncology/hematogy
ICON plc
full-time
Posted on:
Origin: • 🇨🇦 Canada
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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.
Requirements
- 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 oncology/hematology (blood cancers)
- Experience working on a global level
- Candidate must reside in Eastern Canada - limited travel may be required
- Experience in external provider oversight and management
