Global Clinical Data Manager — Lead Data Integrity

BioCryst Pharmaceuticals; North Carolina; Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks a Sr. Clinical Data Manager to lead the global data management lifecycle from start-up through database lock and regulatory submission support.

You will coordinate with CROs, internal stats, labs, and trial operations, ensuring data quality, timely cleaning, and compliant EDCS. Requires 5+ years in CDM and Medidata Rave experience for Phase I–III trials.

Qualifications

• Bachelor's degree in biological sciences, biometrics or related field.
• Minimum of 5 years DM experience with at least two years at a Sponsor company.
• Experience with Medidata Rave EDC software.
• Experience with Phase I–III trials, preferably global.
• Experience with interim analyses and database freeze/lock.
• Excellent communication and time management across teams.
• Ability to prioritize study load and tasks.
• Autonomous, independent and proactive in CDM leadership.

Responsabilités

• Develop and manage global clinical study data management from start-up to database lock.
• Coordinate with DM CROs, internal BioStats, labs and trial operations.
• Maintain data listings, data cleaning, and query resolution.
• Ensure eCRFs, edit checks and DMPs meet study requirements.
• Support Medidata Rave system updates and related UAT/documentation.
• Collaborate with statistics and clinical teams for data transfers and reports.
• Track CDM milestones and generate metrics for study leadership.
• Assist with audit readiness and regulatory submission support.

Connaissances

Clinical Data Management

Medidata Rave

Study data coordination

Regulatory submission support

Data quality control

Formation

Bachelor's degree in biological sciences or related field

Outils

Medidata Rave EDC

Description du poste

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks a Sr. Clinical Data Manager to lead the global data management lifecycle from start-up through database lock and regulatory submission support.

You will coordinate with CROs, internal stats, labs, and trial operations, ensuring data quality, timely cleaning, and compliant EDCS. Requires 5+ years in CDM and Medidata Rave experience for Phase I–III trials.