Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct, manage, and implement comprehensive data management processes for clinical trials conducted either in-house or through CROs.

• Create and uphold Data Management Plans (DMPs), Case Report Forms (CRFs), edit check specifications, and other critical documentation.

• Supervise the database construction.

• Guarantee prompt and high-quality data collection, cleaning, reconciliation, and database locking activities.

• Collaborate across various functions including Clinical Operations, Biostatistics, Regulatory Affairs, Quality Assurance, and external CROs/vendors.

• Ensure the integrity of data and compliance with GCP, FDA, MDR/IVDR, and other relevant regulatory standards.

• Engage in and contribute to the development of protocols, design of case report forms, and creation of data flow diagrams.

• Conduct and oversee data reconciliation, integration of external data (labs, imaging, etc.), and coding of medical terminology (MedDRA, WHO-DD).

• Provide study-specific reports and data listings regularly and respond to ad-hoc requests.

• Assist in audit readiness and participate in regulatory inspections as needed.

• Mentor junior team members and offer strategic insights for process improvements and development of standard operating procedures (SOPs).

⛳️ Requirements

• Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or a related discipline.

• Over 7 years of experience in clinical data management, including a minimum of 2 years in a senior or leadership position.

• Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.).

• Strong knowledge of EDC systems and data standards (CDASH, SDTM, CDISC).

• Familiarity with regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR).

• Exceptional organizational, leadership, and communication abilities.

🏝️ Benefits

• Health insurance

• Professional development

• Flexible work arrangements