Remote Clinical Research Manager

MSD; Stati Uniti; Remoto; USD 142.000 - 224.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long-term incentive

Descrizione del lavoro

MSD is seeking a Clinical Research Manager to oversee end-to-end performance for assigned protocols across a country in compliance with ICH GCP and local regulations. You will drive feasibility, site selection, recruitment, execution, and closeout while coordinating with country operations and the clinical trial team.

This remote role involves leading local study teams, training local staff, and coordinating with CRA, PV, Regulatory and GMA to ensure high performance and compliant outcomes.

Competenze

• 5+ years of experience in clinical research.
• Bachelor’s degree in science (or comparable).

Mansioni

• Main POC for assigned protocols and links between Country Operations and clinical trial team (CTT).
• Plan, drive, and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and closeout.
• Accountable for performance 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.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or vendor and internal management as needed.
• Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol other local roles, collaborates with CRAs as protocol expert and coordinates activities across the different local country roles ensuring 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 to TA Head/CRD as appropriate
• Collaborates with outsourcing vendors, investigators, and external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols
• Serves local business needs and can sign contracts and manage budgets if delegated
• Collaborates with HQ functions and locally with PV, Regulatory and GMA to align on key decisions
• As a customer-facing role, builds business relationships and represents our company with investigators
• Shares protocol-specific information and best practices across countries/clusters

Conoscenze

Project Management

Site Management

Leadership

Regulatory Understanding

Communication

Formazione

Bachelor’s degree in science (or comparable)

Advanced degree (e.g., Master, MD, PhD)

Descrizione del lavoro

MSD is seeking a Clinical Research Manager to oversee end-to-end performance for assigned protocols across a country in compliance with ICH GCP and local regulations. You will drive feasibility, site selection, recruitment, execution, and closeout while coordinating with country operations and the clinical trial team.

This remote role involves leading local study teams, training local staff, and coordinating with CRA, PV, Regulatory and GMA to ensure high performance and compliant outcomes.