Global Clinical Data Manager — Lead for Rare-Disease Trials

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 110,000 - 140,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Clinical Data Manager to oversee global data management from study start-up to database lock and regulatory submission support.

You will coordinate with CROs, internal statisticians, and vendors to define data requirements and ensure data quality across trials. Ideal candidates have a minimum of five years in data management, strong Medidata Rave experience, and familiarity with Phase I–III global studies.

Qualifications

• Bachelor’s degree in biological sciences, biometrics, mathematics, 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.

Responsibilities

• Develop and own data management processes from study start-up to database lock and regulatory submission support.
• Coordinate with CROs, internal BioStats, vendors, and trial operations to define data management requirements.
• Lead data cleaning, query issuance, and data listings for laboratory and database data.
• Ensure readiness of SOPS, eCRFs, and DMPs to meet study requirements and updates as needed.
• Collaborate with DM CROs to reconcile data across vendors and ensure timely data entry and quality.

Skills

Clinical Data Management

Medidata Rave

Global trials

Communication skills

Project coordination

Education

Bachelor’s degree in biological sciences or related field

Tools

Medidata Rave EDC

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Clinical Data Manager to oversee global data management from study start-up to database lock and regulatory submission support.

You will coordinate with CROs, internal statisticians, and vendors to define data requirements and ensure data quality across trials. Ideal candidates have a minimum of five years in data management, strong Medidata Rave experience, and familiarity with Phase I–III global studies.