Clinical Trial Manager

hace 15 horas

Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Trial Manager to join our team at Syneos - Clinical And Corporate - Prod. As a Clinical Trial Manager, you will be responsible for overseeing site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.

Key Responsibilities
  • Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
  • Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.
  • Identifies critical data and process, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
  • Reviews the study scope of work, budget, and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
  • Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
  • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality, and budget) and any activities and requests which are out of contracted scope.
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Participates and presents in key meetings such as Kick Off Meeting.
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
  • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment, and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets, and database lock timelines.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
  • Ensures CTMS, dashboards, and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
  • Ensures access and audit trail reviews are conducted as required.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and guidelines, data plans, and timelines for the study.
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct, and identifies risks to delivery or quality.
  • Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.
  • Reviews the project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities.
Requirements
  • Strong clinical trial management experience with a focus on site management, clinical monitoring, and central monitoring deliverables.
  • Excellent communication and problem-solving skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
  • Strong analytical and technical skills, with experience in clinical trial management systems (CTMS) and other clinical trial systems.
  • Ability to work collaboratively with cross-functional teams, including study start-up, patient recruitment, and data management.
  • Strong attention to detail and ability to maintain accurate records and reports.

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