Global Clinical Data Manager | Medidata Rave Expert

BioCryst Pharmaceuticals; North Carolina; On-site; USD 120,000 - 150,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a Sr. Clinical Data Manager to own the global clinical data management lifecycle from start-up through database lock and regulatory submission support.

You will coordinate with the DM CRO, biostatistics, labs, programming, and trial operations to define data management requirements and ensure high-quality data capture. You will lead data cleaning, issue queries, and maintain eCRFs, edit checks, SOPs, and DMPs across multiple vendors, while collaborating with

Qualifications

• Bachelor's degree in biological sciences or related field (or equivalent).
• Minimum 5 years DM experience with at least 2 years at a Sponsor company.
• Experience with Medidata Rave EDC software.
• Experience with Phase I–III global trials.
• Experience with interim analyses and database locking.

Responsibilities

• Develop and manage global clinical study data management from startup to database lock and regulatory submission support.
• Coordinate with DM CRO, biostats, labs, database programming and trial operations to define data management requirements.
• Lead data cleaning, issue queries, and ensure timely, quality data capture across sites and vendors.
• Oversee EDC, edit checks, SDS/ DMP updates and associated documentation.
• Collaborate with stats, clinical teams and CROs to meet study milestones and regulatory deliverables.
• Support audit and inspection readiness activities and contribute to study-level metrics.

Skills

Data management leadership

Medidata Rave EDC

Clinical data management

Communication

Project coordination

Education

Bachelor's degree in biological sciences or related

Tools

Medidata Rave

Job description

BioCryst Pharmaceuticals seeks a Sr. Clinical Data Manager to own the global clinical data management lifecycle from start-up through database lock and regulatory submission support.

You will coordinate with the DM CRO, biostatistics, labs, programming, and trial operations to define data management requirements and ensure high-quality data capture. You will lead data cleaning, issue queries, and maintain eCRFs, edit checks, SOPs, and DMPs across multiple vendors, while collaborating with