Remote Clinical Data Manager — Drive Data Quality & Compliance

Proclinical Consulting; Boston (KY); Remote; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Proclinical Consulting is seeking a Clinical Data Manager to join our Clinical Data Management team supporting rare disease and pharmaceutical studies. You will ensure data accuracy, compliance, and readiness for analysis while collaborating with CROs and cross-functional study teams.

The role emphasizes data management processes, database validation, and regulatory adherence, with remote US work and a focus on high-quality data standards to impact patient outcomes.

Qualifikationen

• Bachelor's degree in mathematics, science or related field.
• Experience in clinical data management within biotechnology or pharmaceuticals.
• Ability to coordinate CRO data managers and project teams per SOPs.
• Solid understanding of data management processes, database validation and regulatory compliance.
• Strong collaboration, organizational and communication skills.
• Preferred experience in genetics, oncology or ophthalmology.

Aufgaben

• Act as the primary data management contact for assigned studies with CRO partners.
• Lead CDM activities in line with company SOPs and regulatory requirements.
• Oversee CRO data clean-up from start-up to archiving to ensure quality.
• Manage medical coding, data validation checks, and database snapshots.
• Create and maintain study documents including DM Manual and CRF guidelines.
• Design and modify CRFs and oversee build, test and validation of databases.
• Prepare and distribute project status reports to teams and management.
• Lead the data management team to ensure validated databases for transfer and analysis.

Kenntnisse

CRO Coordination

Data Management

Regulatory Compliance

Data Validation

Communication Skills

Ausbildung

Bachelor's degree in Mathematics or Science

Jobbeschreibung

Proclinical Consulting is seeking a Clinical Data Manager to join our Clinical Data Management team supporting rare disease and pharmaceutical studies. You will ensure data accuracy, compliance, and readiness for analysis while collaborating with CROs and cross-functional study teams.

The role emphasizes data management processes, database validation, and regulatory adherence, with remote US work and a focus on high-quality data standards to impact patient outcomes.