JOB SUMMARY:
The Sr. Clinical Data Manager is responsible for developing and managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support. This position coordinates activities with the DM Contract Research Organization (CRO), internal and external biostats, laboratory vendors, database programming and trial operations to define and implement data management requirements.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Ability to develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization including the ability to develop, run, review, and maintain data listings for laboratory and database data.
- Proactively identifies risks and flags findings during ongoing study to clinical management and may develop materials and present to CRAs, sites to ensure consistent, quality data capture.
- Facilitates and leads all data cleaning including issuing queries along with guidance on issuance and acceptable closure of queries on an ongoing basis.
- Demonstrates a strong understanding of the assigned study protocol(s), critical tasks, and associated milestones.
- Ensures completeness, correctness and consistency of routine clinical data and its structure.
- Work closely with DM CRO to ensure weekly reconciliation with multiple vendors for timely and quality data entry, lab completion and resulting, and eDiary data entry and compliance.
- Work closely with DM CRO to ensure all eCRFs, CCGs, Edit Checks, SOPs and DMPs meet study requirements and assist with updates as required.
- Assistance with any required updates to the Medidata Rave EDC system and associated UAT, and updated documentation.
- Works collaboratively with both internal team members and associated CROs / vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, documents required for regulatory submission and assistance as needed.
- Close collaboration with Stats and Clinical teams to manage frequent DMC meetings including timeline development, data cleaning, management of EDC and lab data transfers, and more.
- Aid study manager in managing and tracking database interim review and lock timelines and ensure CDM project milestones are met in coordination with the project team.
- Develop and maintain relevant report metrics to share with overall study team and upper management. The ability to note and monitor trends across regions will be key.
- Ability to support the clinical team with additional ad-hoc tasks such as newsletter preparation and CRA training.
- Support study-level audit and inspection readiness activities, as needed.
- All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
- Bachelor’s degree, with a focus 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.
- Ability to prioritize study load and associated tasks.
- 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.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, is committed to achieving its business objectives in compliance with all federal, state and local law.
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