Remote opportunity at
BioCrystSr. Clinical Data Manager (contract)
BioCryst seeks a remote, contract-based Sr. Clinical Data Manager to lead global clinical study data management operations from the initial start-up phase through database lock and…
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About This Role
BioCryst seeks a remote, contract-based Sr. Clinical Data Manager to lead global clinical study data management operations from the initial start-up phase through database lock and regulatory submissions. This professional will coordinate data activities alongside contract research organizations, biostatistics teams, laboratory vendors, and trial operations. The role requires establishing ownership over compilation, tracking, cleaning, and finalization processes, as well as managing vendor reconciliation and Medidata Rave EDC system updates. This…
Job Description
BioCryst seeks a remote, contract-based Sr. Clinical Data Manager to lead global clinical study data management operations from the initial start-up phase through database lock and regulatory submissions. This professional will coordinate data activities alongside contract research organizations, biostatistics teams, laboratory vendors, and trial operations. The role requires establishing ownership over compilation, tracking, cleaning, and finalization processes, as well as managing vendor reconciliation and Medidata Rave EDC system updates.
This position is suited for an autonomous specialist who can proactively identify risks, manage data cleaning, and maintain project milestones across Phase I, II, and III trials. BioCryst operates as an equal opportunity employer committed to compliance with federal, state, and local regulations regarding protected classes.
Responsibilities
- Develop and oversee processes for data compilation, tracking, maintenance, cleaning, and finalization, including laboratory and database listings
- Identify risks proactively and present findings to clinical management, CRAs, and study sites
- Lead data cleaning operations by issuing and closing queries on a regular basis
- Partner with the data management CRO to guarantee weekly vendor reconciliation for data entry, lab results, and eDiary compliance
- Collaborate with the CRO to verify that eCRFs, CCGs, edit checks, SOPs, and data management plans align with protocol needs
- Support updates and UAT testing for the Medidata Rave EDC system
- Manage DMC meetings in coordination with stats and clinical groups
- Track database review and lock timelines to satisfy project milestones
- Create and monitor metric reports to share trends with leadership and the study team
- Assist the clinical team with ad-hoc tasks like newsletter creation, CRA training, and audit readiness
Requirements
- Minimum of five years of data management experience
- At least two years of experience working at a sponsor company
- Familiarity with Medidata Rave EDC software
- Direct involvement with Phase I, 2, and 3 clinical trials
- Experience with interim analyses, freezing, and database locking
Qualifications
- Bachelor's degree in biological sciences, biometrics, mathematics, or a related field
- Equivalent combination of education and relevant experience
- Experience with global clinical trials
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the posting specifies that the role is remote.
What is the employment type?
This is a contract position.
What level of experience is required?
Candidates must have a minimum of five years of data management experience, with at least two of those years spent working at a sponsor company.
What is the salary for this role?
The salary is not stated in the job posting.
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