Senior Clinical Data Manager – Contract

🔥 12 hours 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 through database lock and regulatory submission support • Coordinate with the DM CRO, internal and external biostatistics, laboratory vendors, database programming, and trial operations to define and implement data management requirements • Develop and own processes for data compilation, tracking, maintenance, cleaning, and finalization • Develop, run, review, and maintain laboratory and database data listings • Identify risks and flag findings during ongoing studies; develop materials and present to CRAs and sites to support consistent, quality data capture • Lead data cleaning, including issuing queries and guiding acceptable query closure • Ensure completeness, correctness, and consistency of routine clinical data and structure • Coordinate weekly reconciliation with multiple vendors for timely and quality data entry, laboratory completion and resulting, and eDiary data entry and compliance • Ensure eCRFs, CCGs, Edit Checks, SOPs, and DMPs meet study requirements and assist with updates • Support updates to the Medidata Rave EDC system, associated UAT, and documentation • Collaborate with internal teams, CROs, and vendors to meet clinical data acquisition, quality review, clinical study report, and regulatory submission deliverables and timelines • Collaborate with Statistics and Clinical teams to manage DMC meetings, timelines, data cleaning, EDC and laboratory data transfers, and related activities • Aid the study manager in tracking database interim review and lock timelines and ensure CDM milestones are met • Develop and maintain report metrics, including monitoring trends across regions, for the study team and upper management • Support ad hoc clinical team tasks such as newsletter preparation and CRA training • Support study-level audit and inspection readiness activities as needed • 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 • Ability to work autonomously and independently, take initiative, and manage, own, and lead all aspects of DM

🏖️ Benefits

• Equal employment opportunity commitment • Compliance with federal, state, and local law