Senior Clinical Data Manager

🔥 3 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Develop and manage all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support • Coordinate 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 • Develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization • Develop, run, review, and maintain data listings for laboratory and database data • Identify risks and flag findings during ongoing studies to clinical management • Develop materials and present to CRAs and sites to ensure consistent, quality data capture • Facilitate and lead data cleaning, including issuing queries and providing guidance on query issuance and acceptable closure • Ensure completeness, correctness, and consistency of routine clinical data and its structure • Coordinate weekly reconciliation with multiple vendors for timely and quality data entry, lab completion and resulting, and eDiary data entry and compliance • Ensure eCRFs, CCGs, Edit Checks, SOPs, and DMPs meet study requirements and assist with updates • Assist with Medidata Rave EDC system updates, associated UAT, and updated documentation • Collaborate with internal team members, CROs, and vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, regulatory submission documents, and other needs • Collaborate with Stats and Clinical teams to manage frequent DMC meetings, including timeline development, data cleaning, and management of EDC and lab data transfers • Aid the study manager in managing and tracking database interim review and lock timelines and ensure CDM project milestones are met • Develop and maintain report metrics for the overall study team and upper management, monitoring trends across regions • Support the clinical team with ad-hoc tasks such as newsletter preparation and CRA training • Support study-level audit and inspection readiness activities • Perform other duties as assigned

🎯 Requirements

• 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

🏖️ Benefits

• 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 • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities