Remote CTM II: Clinical Trial Management Lead

Syneos Health, Inc.; Buenos Aires; Remoto; ARS 90.836.000 - 136.254.000; Tempo integral

Resumo da vaga

Syneos Health in Argentina is seeking a CTM II to oversee site management, clinical monitoring and central monitoring deliverables, with focus on patient safety, GCP compliance and data integrity. You will interact with CRAs, central monitors and investigators to ensure delivery of milestones.

The role requires leadership in a global environment, budget awareness, risk mitigation, and training of study teams.

Qualificações

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Ability to lead and align teams to achieve project milestones.
• Experience working in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Knowledge of risk-based monitoring preferred.
• Understanding of clinical trial management financial principles and budgets.
• Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Strong computer skills.
• Good communication, presentation and interpersonal skills.
• Conflict resolution skills.
• Ability to apply problem solving techniques to resolve issues and manage risk.
• Ability to think critically and manage travel requirements.

Responsabilidades

• Oversees 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 or related activities.
• Identifies data/process risks and mitigations related to RA/RAC T.
• Reviews study scope, budget and protocol content; ensures project team is aware of obligations.
• Uses data and metrics to identify risks to trial deliverables.
• Escalates risks to the project manager for timeline, quality, and budget issues.
• Proposes risk mitigations and participates in key meetings.
• Interacts with investigator site staff and may accompany CRA teams.
• Collaborates with Study Start Up, Patient Recruitment and Data Management to meet milestones.
• Develops and maintains clinical study tools and templates including the Clinical Monitoring Plan; oversees CTMS and dashboards.

Conhecimentos

Leadership

International environment

Site management & monitoring

Risk-based monitoring

Budget management

GCP/ICH knowledge

Computer skills

Communication skills

Problem solving

Critical thinking

Travel readiness

Formação

Bachelor’s degree or RN in a related field

Ferramentas

CTMS

EDC

TMF

Descrição da vaga

Syneos Health in Argentina is seeking a CTM II to oversee site management, clinical monitoring and central monitoring deliverables, with focus on patient safety, GCP compliance and data integrity. You will interact with CRAs, central monitors and investigators to ensure delivery of milestones.

The role requires leadership in a global environment, budget awareness, risk mitigation, and training of study teams.