Clinical Trial Manager

Clinical Trial Manager

ICON

Spain

You will 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, the Monitoring Plan and ensuring the clinical portion of the study is inspection ready at all times.

What you will be doing:

• Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• 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 Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) 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 and may take the role of a Global CTM if appropriate.
• Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including 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 participate in the conduct of clinical team meetings.
• Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.
• Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
• Lead clinical resources in a matrix environment, as required, including Clinical Trial Assistants and Clinical Research Associates.
• Set expectations for the study team and drive a performance culture through their teams:
  • Develop supporting staff skills, encourage growth and provide regular performance feedback.
  • Act as mentor and help to train junior staff.
  • Communicate expectations, set clear goals and objectives for the study(ies) to clinical team members.
  • Lead by example and motivate all assigned clinical team members.

You are:

• Bachelor's or advanced degree in a relevant scientific discipline.
• Minimum of 5 years of experience in Clinical Operations.
• In-depth knowledge of clinical trial regulations, guidelines, and best Practices.
• Demonstrated experience in managing and executing clinical trials from start-up to closeout.
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary.
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations.

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