Clinical Trial Manager (CTM) - Mexico
syneoshealth · MEX-Mexico City-Hybrid
Descripcion del puesto
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.
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Publicado hace 11 horas
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syneoshealth
MEX-Mexico City-Hybrid
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