Assoc. Dir, Clin. Operations

Merck Gruppe - MSD Sharp & Dohme; São Paulo; Hybrid; BRL 180,000 - 260,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking a Clinical Project Manager to oversee end-to-end performance and project management for assigned protocols in a Brazil/São Paulo setting, ensuring compliance with ICH/GCP and local regulations. The role may cover multiple countries within a cluster and requires strong cross-functional collaboration with Country Operations and the Clinical Trial Team.

Responsibilities include leading local study teams, training CRAs, managing risks, and ensuring

Qualifications

• Experience in clinical research and interventional trials.
• Solid experience as a Clinical Project Manager for interventional trials.
• CRA experience is preferred.
• Advanced English proficiency required.

Responsibilities

• Main POC for assigned protocols and liaison between Country Operations and Clinical Trial Team (CTT).
• Plan, drive, and track execution and performance to meet country commitments from feasibility to close-out.
• Ensure compliance with ICH/GCP, country regulations and company policies; review monitoring visits and training needs.
• Lead local study teams, train CRA staff, and coordinate activities across local roles for high performance.
• Create and execute local risk management plans for assigned studies.
• Ensure CTMS, eTMF, and other key systems are used correctly; escalate issues as needed.
• Collaborate with vendors, investigators, and external partners; be country POC for outsourced trials.
• Represent the company to investigators and build business relationships.

Skills

Clinical Research

Clinical Project Management

CRA experience

Advanced English

Education

Bachelor's degree in Science

Advanced degree (Masters/MD/PhD)

Job description

Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

For certain studies, the CRM could be responsible for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• Responsible for project management of the assigned studies: proactively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close-out.
• Accountable for performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA Manager and/or functional vendor and internal management as needed. Performs Quality Control visits as required.
• Leads local study teams to high performance: trains other local roles on the protocol, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles, ensuring strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalates challenges and issues as needed to TA Head/CRD/CQM and/or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his/her country (if delegated, can sign contracts and manage budgets).
• Collaborates internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent our company with investigators.
• Shares protocol-specific information and best practices across countries/clusters.

Qualifications & Experience

Required

• Experience in Clinical Research.
• Solid experience as a Clinical Project Manager for interventional trials.
• CRA experience.
• Advanced English proficiency.

Educational Requirements

Required

• Bachelor’s degree in Science (or comparable).

Preferred

• Advanced degree (e.g., Master's degree, MD, PhD).

Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado.

ClinicalTrialsBR