Global Clinical Data Manager — Data Integrity & Submissions

BioCryst; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

BioCryst is seeking a Sr. Clinical Data Manager to lead the global data management process from study start-up to database lock and regulatory submissions.

You will coordinate with the DM CRO, biostatistics, laboratories, and trial operations to define and implement data management requirements and ensure data integrity. The role requires a Bachelor’s in a biological science field and at least five years of data management experience, including Medidata Rave EDC proficiency and global Phase

Qualifications

• Bachelor’s degree in biological sciences, biometrics, mathematics, or equivalent.
• Minimum of 5 years DM experience with at least two years at a Sponsor company.
• Experience and familiarity with Medidata Rave EDC software.
• Experience and familiarity with Phase I, 2 and 3 trials, preferably global.
• Excellent communication and time management skills, including collaboration across functional disciplines.
• Chosen candidate must be autonomous, independent and must take initiative to manage, own, and lead all aspects of DM while contributing to overall study team.

Responsibilities

• Develop and manage data management processes from start-up to database lock.
• Coordinate with DM CROs, biostats, laboratory vendors, database programming and trial operations to define data management requirements.
• Lead data cleaning and issue queries with guidance on closure of queries.
• Ensure completeness, correctness and consistency of routine clinical data and its structure.
• Work with DM CRO to ensure weekly reconciliation with vendors for timely data entry, lab results, and eDiary data entry.
• Assist with updates to Medidata Rave EDC system and associated UAT and documentation.
• Collaborate with internal teams and CROs/vendors to meet project deliverables and timelines for data acquisition and regulatory submission documents.
• Coordinate with Stats and Clinical teams for DMC meetings, data transfers, and related tasks.
• Aid study manager in tracking database interim reviews and lock timelines.
• Develop and maintain report metrics and monitor trends across regions.
• Support ad-hoc tasks such as newsletter preparation and CRA training.
• Support study-level audit and inspection readiness activities.

Skills

Clinical data management

Data cleaning

Risk assessment

Study coordination

Medidata Rave

Regulatory submission

Communication skills

Time management

Independent initiative

Education

Bachelor’s degree in biological sciences

Tools

Medidata Rave

Job description

BioCryst is seeking a Sr. Clinical Data Manager to lead the global data management process from study start-up to database lock and regulatory submissions.

You will coordinate with the DM CRO, biostatistics, laboratories, and trial operations to define and implement data management requirements and ensure data integrity. The role requires a Bachelor’s in a biological science field and at least five years of data management experience, including Medidata Rave EDC proficiency and global Phase