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Clinical Trial Manager (CTM) - Mexico

syneoshealth · MEX-Mexico City-Hybrid

New
Hybrid Mid 🇬🇧 English
ICH GCP Electronic Data Capture (EDC) Risk-based monitoring

Job description

About the role

Syneos Health is looking for a Clinical Trial Manager (CTM) based in Mexico City, working in a hybrid setting. The role covers site management oversight, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. The posting states it is for a possible upcoming opportunity and interested candidates are added to the talent pipeline.

Key responsibilities

  • Oversee site interactions from post-activation through closeout, including patient recruitment and investigator payments.
  • Identify risks to clinical trial management deliverables and escalate them to the project manager; propose and implement risk mitigations.
  • Take part in key meetings such as the Kick Off Meeting and act as an escalation point for communications with investigator site staff, sometimes accompanying CRAs to sites.
  • Collaborate with Study Start Up, Patient Recruitment and Data Management to meet milestones such as site activation, enrollment and database lock targets.
  • Maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and other systems, including UAT.
  • Coordinate training for the study team on protocol, CRFs, SOPs and data plans, and oversee resourcing of CRAs and Central Monitors.
  • Review monitoring documentation and dashboards (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS) and support inspection readiness.
  • Provide status updates and solutions to the client and leadership, and give feedback to line managers on staff performance.

Required profile

  • Bachelor's degree or RN in a related field, or equivalent education, training and experience.
  • Previous clinical trial experience in site management; risk-based monitoring and clinical or central monitoring experience preferred.
  • Ability to lead and align teams, work in an international environment and moderate travel (about 20%).

Required skills

  • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
  • Familiarity with financial principles and budget management.
  • Good computer skills, communication and presentation skills, and basic conflict resolution.
  • Problem-solving and risk management approach to clinical research projects.

Questions fréquentes

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Source : ats:workday

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Published 11 hours ago

Expires 1 month from now

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syneoshealth

MEX-Mexico City-Hybrid