RBM Central Monitoring Manager – Data-Driven Study Oversight

Teva Pharmaceuticals; West Chester (Chester County); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) with company match

Paid time off

Flexible working options

Zusammenfassung

Teva Pharmaceuticals is seeking a Manager, Centralized Monitoring to lead RBM strategy across assigned studies within Global Biometrics. You will develop and implement CMPs, and build dashboards using CSA and Spotfire to assess data quality and risk in real time.

You will partner with Medical Monitoring, Clinical Operations and Data Management to drive data-driven decisions, improve oversight, and ensure compliance with regulatory guidance.

Qualifikationen

• 5+ years of professional experience required.
• Bachelor's degree or higher or equivalent experience.
• Strong oral and written communication skills.
• Ability to manage multiple projects independently.
• Experience with RBM practices and strategies preferred.
• Knowledge of regulatory guidance (ICH E6 R2, Transcelerate) preferred.

Aufgaben

• Lead and implement the risk assessment process on assigned studies and facilitate cross-functional input.
• Map study risks to data and procedures to define oversight responsibilities.
• Author and maintain CMP describing aggregate and real-time reviews.
• Perform regular reviews to identify trends and data anomalies.
• Develop and monitor quality and risk indicators to improve data quality.
• Design tools and dashboards (CSA and Spotfire) for review cycles.
• Collaborate with Medical Monitoring, Clinical Operations, and Data Management teams.
• Oversee issues management across the study life cycle.

Kenntnisse

Communication skills

Project management

Virtual collaboration

RBM knowledge

Regulatory knowledge

Ausbildung

Bachelor's degree or higher

Tools

Medidata CSA

Spotfire

Jobbeschreibung

Teva Pharmaceuticals is seeking a Manager, Centralized Monitoring to lead RBM strategy across assigned studies within Global Biometrics. You will develop and implement CMPs, and build dashboards using CSA and Spotfire to assess data quality and risk in real time.

You will partner with Medical Monitoring, Clinical Operations and Data Management to drive data-driven decisions, improve oversight, and ensure compliance with regulatory guidance.