Kelly is currently seeking a Global Trial Manager with Managed Access experience for a long term engagement with one of our Global clients.
This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All KellyOCG employees receive annual performance reviews.
The Global Trial Leader Managed Access Program provides global, regional or complex local management of a Managed Access clinical trial s in a country or countries. Services/deliverables include operational oversight of assigned projects at the country level for end to end project management including start-up, execution, close-out, analysis and reporting. Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures SOPs , International Conference on Harmonization for Good Clinical Practice ICH-GCP , and regulatory requirements.
Partners with the Clinical Program Leader CPL , Clinical Operations Head COH , Global Clinical Trial Assistant GCTA MAO , and other Global Trial Leaders GTL to ensure overall study delivery at the country level.
Coordinates with global teams and physicians to streamline patient access into closed studies.
Deliverables: Services rendered will adhere to applicable clients SOPs, WIs, policies, codes of Good Clinical Practice GCP , local regulatory requirements, etc.
Complies with relevant training requirements.
Prepares high level budget estimate in response to Request for Services followed by detailed budget proposal. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket OOP costs and FTE costs.
Responsible for overall contract management, including review and approval of external service provider ESP contracts, change orders and ensures services are delivered per contract.
Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
Participates in preparation for and conduct of Health Authority HA inspections and internal Quality Assurance audits.
Escalates corrective and preventive actions CAPA to GTL and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required.
As required, manages the local study drug supply. Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes creating, reviewing, and managing site specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilities.
Bachelor’s degree required
Demonstrated relevant project management experience a must
Global Project leadership experience
Excellent cultural awareness
Experience influencing and managing others
Very strong organization skills
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