(Sr.) Clinical Trial Manager- CNS/Rare Diseases (home based)

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:
o high performance and productivity (e.g. DOS for CRAs)
o optimal utilization
o minimal turnover
o 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.

• *Recognize, exemplify and adhere to ICON's values which center 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.
 

You will need:
• 4 year degree or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in CNS, or Rare Diseases
• Prior monitoring experience is preferred
• Ability to travel up to 20%
• Fluent in local language - both written & verbal

Benefits of Working in ICON: