Senior Clinical Data Manager, Remote Lead

Veristat; Massachusetts; Hybrid; USD 114.000 - 150.000; Vollzeit

Benefits dieser Stelle

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Zusammenfassung

Veristat is seeking a Principal Clinical Data Manager to independently manage data tasks from study start-up to database lock across various indications. You will lead a CDM team, oversee both paper-based and EDC studies, and ensure high data quality and SOP compliance.

You will mentor junior staff, collaborate with management, and train other functions as needed, while applying ICH GCP knowledge and CRO industry understanding.

Qualifikationen

• Bachelor's degree and 7+ years of relevant experience; at least 5 years in clinical data management and 4 years leading project teams.
• Thorough knowledge of ICH GCP guidelines and other regulatory rules.
• Understanding CRO relationships with pharma/biotech companies.
• Ability to lead by example and mentor staff on data management processes.
• Strong ability to think strategically, communicate effectively, and manage multiple projects.

Aufgaben

• Lead data management tasks from study start-up through database lock for multiple projects.
• Oversee paper-based and EDC studies, ensuring data quality and documentation.
• Manage a CDM team and ensure adherence to SOPs and sponsor requirements.
• Train other data managers and provide cross-functional training when needed.

Kenntnisse

Clinical Data Management

Project Leadership

Regulatory Knowledge

SOP Compliance

Ausbildung

Bachelor's degree in a related field

Tools

Medidata RaveX

IBM Clinical Development

Jobbeschreibung

Veristat is seeking a Principal Clinical Data Manager to independently manage data tasks from study start-up to database lock across various indications. You will lead a CDM team, oversee both paper-based and EDC studies, and ensure high data quality and SOP compliance.

You will mentor junior staff, collaborate with management, and train other functions as needed, while applying ICH GCP knowledge and CRO industry understanding.