Principal Clinical Data Manager - Remote Position

Role Summary

As Principal Clinical Data Manager, you will lead study data management activities, including coordination of CRF design, development, review and sign-off; review and approve CRO data management documents; coordinate database live and close-out activities with CRO; provide guidance to CRO to manage query flow and implement a quality control plan. You may participate in vendor audits, statistical analysis plans, vendor qualification and selection, and vendor performance monitoring. This is a remote position.

Responsibilities

• Reviews listings to identify data discrepancies and tracks resolutions
• Works with Study team to design mock CRFs based on the protocol
• Leads database design, implementation and testing activities
• Supervises all data management deliverables and associated timelines with the CRO to ensure a quality database lock
• Coordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

Qualifications

• Required: Minimum of 7 years of biometrics/data management or related experience in the biotechnology/pharmaceutical industry
• Required: Familiarity with data management software (e.g. Medidata, Oracle Clinical)
• Required: Working knowledge of coding dictionaries – MedDRA and WHODRUG
• Preferred: Knowledge of Oncology clinical trials
• Preferred: Nursing background
• Preferred: Vendor management experience
• Preferred: Familiarity with SAS
• Preferred: Knowledge of Excel, Python, or R is helpful

Skills

• Excellent organizational skills and ability to prioritize tasks
• Must be able to work under tight timelines
• Possess excellent communication skills
• Anticipates change and reacts quickly and intelligently to accommodate business needs

Education

• Bachelor’s Degree in a biological sciences or other medically related areas

Additional Requirements

• Travel may be required (up to 5%)
• Physical demands: The role may require extended sitting and computer use; occasional standing, walking; ability to lift up to 25 pounds; and vision requirements