Senior Clinical Data Manager – Contract

🔥 14 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 study start-up through database lock and regulatory submission support • Coordinate data management activities with the DM Contract Research Organization, internal and external biostatistics, laboratory vendors, database programming, and trial operations • 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 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, laboratory completion and results, and eDiary 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 deliverables and timelines for clinical data acquisition, quality review, clinical study reports, and regulatory submission documents • Collaborate with Statistics and Clinical teams to manage DMC meetings, timelines, data cleaning, EDC and laboratory data transfers, and related activities • Assist the study manager with tracking database interim review and lock timelines and meeting CDM milestones • Develop and maintain report metrics for the study team and upper management, including monitoring trends across regions • 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 of data management experience, including at least 2 years at a sponsor company • Experience and familiarity with Medidata Rave EDC software • Experience and familiarity with Phase I, II, and III 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 • Must be autonomous and independent, take initiative, and manage, own, and lead all aspects of data management while contributing to the overall study team

🏖️ Benefits

• Contract role • Full-time schedule • Equal employment opportunity protections • Commitment to compliance with federal, state, and local law