Global Clinical Data Manager | Medidata Rave Leader

BioCryst; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

BioCryst is seeking a Sr. Clinical Data Manager to lead global data management from start-up to database lock and regulatory submission support. You will coordinate with the DM CRO, internal and external BioStats, labs, and trial operations to define data management requirements.

Responsibilities include developing data compilation processes, leading data cleaning, overseeing eCRFs and edit checks, and partnering with statistics and clinical teams to meet milestones for regulatory submissions.

Qualifications

• Bachelor’s degree in biological sciences, biometrics, mathematics, etc., or equivalent combination of experience and education.
• 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.
• Experience and familiarity with interim analyses and freezing and locking databases.
• 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 own processes for data compilation, tracking, maintenance, cleaning, and finalization.
• Identify risks and present findings to clinical management and CRAs/sites.
• Lead data cleaning and issue queries with guidance on closures.
• Ensure protocol tasks and milestones are understood and met.
• Ensure completeness and consistency of routine clinical data and structure.
• Coordinate weekly reconciliation with DM CROs and vendors for data entry and lab data.
• Ensure eCRFs, CCGs, Edit Checks, SOPs, and DMPs meet study requirements.
• Support Medidata Rave EDC system updates and related documentation.
• Collaborate with internal teams and CROs to meet project deliverables and timelines.
• Manage DMC meeting timelines and data transfers with Stats and Clinical teams.
• Assist study manager with database interim review and lock timelines.

Skills

Data management

Clinical data management

Communication

Time management

Education

Bachelor’s degree in biological sciences, biometrics, or related field

Tools

Medidata Rave EDC

Job description

BioCryst is seeking a Sr. Clinical Data Manager to lead global data management from start-up to database lock and regulatory submission support. You will coordinate with the DM CRO, internal and external BioStats, labs, and trial operations to define data management requirements.

Responsibilities include developing data compilation processes, leading data cleaning, overseeing eCRFs and edit checks, and partnering with statistics and clinical teams to meet milestones for regulatory submissions.