Senior Manager, Clinical Trial Management

hace 2 meses

Madrid, España Icon plc A tiempo completo

Senior Manager, Clinical Trial Management

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

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies. To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON Standard Operating Procedures (SOPs), applicable regulations, and the Monitoring Plan. Ensuring the clinical portion of the study is inspection ready at all times. May also act as a single service project manager, or as a project manager for small studies.

Recognize, exemplify and adhere to ICON's values which centre 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.

Travel (approximately 25%) domestic and/or international.

Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders. May act as the primary point of contact for smaller or single service projects.

Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments, protocol deviation prevention, tracking and reporting, IP management, timely investigator payments.

Responsible for driving enrolment as per contracted timelines.

Regular oversight of key clinical metrics, including but not limited to : Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action Items (Al) and other quality metrics, to ensure they are met and followed-up as necessary.

Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate.

Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.

Contribute to the development and maintenance of all clinical elements of cross functional project plans.
- Able to work on multinational studies or take the role of a Global CTM.
- *Responsible for co-ordinating, managing and mentoring the clinical project team to ensure
- high performance and productivity (e.g Days on Site for CRAs)
- optimal utilization,
- continuous development
- mínimal turnover
- all necessary project training is provided, documented and filed appropriately.

Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution.

Responsible for the development and maintenance of operational plans for clinical deliverables
e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc.

Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary. This includes documented QC checks of in house investigator site files.

Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.

Lead and/or actively participa

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