Ref #: 26684

Employment type: Permanent - Full-Time

Location: Mexico City

Posted: 04-Feb-2021

Description

Job Function:
• 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.
• 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 (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 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 Company/Departmental initiatives, as requested. Undertake other reasonably related duties as assigned.

Experience:
• minimum of four (4) years of clinical research experience, including monitoring and/or site management activities and supporting clinical trial management activities or equivalent position/experience
• University/Bachelor's Degree in medicine, science or equivalent degree/experience.
• MUST have 1 year of Clinical Project Management experience


• Ex-Icon employees are super welcome to apply!