Clinical Trial Manager - Vaccines (Homebased)

Clinical Trial Manager - Vaccine

Homebased - any US location

Job Profile Summary

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

Job Description

• 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.
• Participate in 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.
• 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 coordinating and managing the clinical project team to ensure:
  • high performance and productivity (e.g. DOS for CRAs)
  • optimal utilization
  • minimal turnover
  • all necessary project training is provided, documented and filed appropriately.
• 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.
• Maintain confidentiality of information, as appropriate.
• Participate in business development activities such as bid defense meetings
• May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager.
• Participate in Company/Departmental initiatives, as requested.
• Undertake other reasonably related duties as assigned.

Requirements

• Previous working experience within the clinical trial management field.
• University/Bachelor's Degree in medicine, science or equivalent degree/experience.
• A satisfactory progression of monitoring experience with previous experience in leadership and/or management activities
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
• Some knowledge of project management processes and tools.
• Fluent in written and spoken English.