Senior Clinical Database Designer

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🕒 vor 2 Monaten

🌐 Vereinigte Staaten, Kanada – Remote

🇺🇸 Vereinigte Staaten – Remote 🇨🇦 Kanada – Remote

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $90.000 - $130.000 / Jahr

⏰ Vollzeit

🟠 Senior

✍️ Designer

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Everest Clinical Research

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Everest Clinical Research ist eine globale Clinical Research Organization (CRO), die umfassende Dienstleistungen im Bereich klinische Studien und Biometrics-Expertise für Pharma- und Biotechnologie-Sponsoren bietet. Das Unternehmen offeriert klinische Operationen und Projektmanagement, risikobasiertes Qualitätsmanagement und zentralisiertes Monitoring, medizinisches Monitoring, Pharmakovigilanz, klinisches Datenmanagement, Biostatistik und statistische Programmierung, regulatorische Strategie und Einreichungen sowie Technologielösungen wie IRT/RTSM und ePRO/eCOA. Everest positioniert sich als ein qualitativ hochwertiger Partner mit globaler Reichweite und therapeutischer Expertise in den Bereichen Onkologie, Neurologie, Atemwegserkrankungen, seltene Krankheiten und Immunologie.

Beschreibung

• Develop new features and functionality within the database design functional areas • Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process • Review the protocol and associated study reference materials • Maintain database design timelines • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices • Design and review case report forms (CRFs/eCRFs) • Author and review the Data Validation Specifications • Develop and review User Acceptance Test (UAT) plans • Coordinate and oversee the UAT process • Design and review patient Case Report Forms and database schema • Test data capture/entry screens through UAT • Participate in EDC vendor’s technical learning and exchange meetings • Provide user training to CRAs on EDC systems • Contribute to the development and maintenance of the company’s database design procedural documents • Plan, manage, control and perform data processing activities for assigned projects • Review the Data Management Plan (DMP) • Review data, issue and resolve queries • Assist in resolving medical coding discrepancies • Cooperate with the Quality Assurance Department with quality control audits • Define and monitor clinical trial data flow and quality control processes • Accurately and efficiently validate electronically captured data • Write clear queries on missing data and data points failing pre-defined range checks • Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.

🎯 Anforderungen

• B.Sc. in Biological Sciences or Computer Science • Five years' related experience • Two to three years developing Inform and/or Medidata Rave (or similar) clinical data bases • Previous Clinical Data Management experience in both paper based and electronic data capture systems • Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels • Proven leadership and interpersonal skills in complex team situations • Excellent presentation skills and ability to build relationships with both internal and external clients • Must be well organized and able to work independently and manage multiple projects/tasks appropriately • Demonstrated ability to effectively organize and integrate the activities of information processing personnel.

🏖️ Vorteile

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a 401(k) retirement • generous paid time off • sick leave • opportunity to earn a performance based bonus