Senior Manager, Clinical Data Management

Role Overview

• Provide timely and professional ongoing management of project and clinical trial data.
• Work closely with outsourced clinical data management (CDM) activities with various Contract Research Organizations (CROs).
• Ensure study team expectations are clearly communicated to the CRO.
• Provide comprehensive data management expertise to deliver efficient data management products.
• Serve as the Lead Data Manager on studies.
• Understand and comply with core standard operating procedures (SOPs).
• Review and approve various CDM documents.
• Communicate ideas for process improvement.
• Provide project updates to management weekly and monthly.

Requirements

• Minimum 8 – 12 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in biotech or pharmaceutical industry.
• Thorough knowledge of the data management process.
• Thorough understanding of clinical trial methodology, GCP and medical terminology.
• Electronic Data Capture (EDC) experience, preferably Rave EDC
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills required.

Tech Stack

• Google Cloud Platform

Benefits

• merit-based salary increases
• overtime
• short incentive plan participation
• eligibility for 401(k) plan
• medical, dental, vision, life and disability insurances
• up to 120 hours of vacation per year
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter
• access to service recognition program