Risk and Central Monitoring Manager (Belén de Escobar)

Who we areWe’re a integral, midsize CRO that pushes boundaries, innovates and invents to work toward cures for persistent diseases. We believe in creative, quality‑driven approaches that enable teams worldwide to succeed. What the Risk and Central Monitoring Manager does at Worldwide Clinical TrialsThis role coordinates cross‑functional risk management and central monitoring activities for assigned clinical trials in accordance with ICH GCP guidelines. The role supports study teams by prioritizing quality across the study and ensuring consistency within programs, therapeutic areas, and/or sponsors. Responsibilities
- Supports Risk-Based Quality Management (RBQM) activities within the assigned project team.
- Understands the study budget and protocol content for assigned trials.
- Oversees all RBQM activities on assigned studies.
- Supports the development of the Project Management Plan for the assigned program or study and may provide advice on the development of other functional plans.
- Develops the Central Monitoring Plan for the assigned study and gains Global Project Lead (GPL) and sponsor approval.
- Delivers training to study teams regarding the RBQM strategy, including study risk assessment, centralized monitoring, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and the overarching monitoring strategy.
- Independently provides subject matter expertise for the development and maintenance of the study‑level monitoring strategy required for the program or trial.
- Drafts and finalizes the initial risk assessment, ensuring cross‑functional involvement.
- Facilitates the identification of KRIs and/or QTLs as part of the study monitoring strategy, when applicable.
- Oversees the set‑up of the central monitoring dashboard and central monitoring reviews performed throughout the study, when applicable.
- Supports the GPL in ensuring compliance with cross‑functional review of risks throughout the trial.
- Performs central monitoring activities, when applica Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qjfif