Senior Clinical Database Designer

Job not on LinkedIn

🕒 May 27

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $90k - $130k / year

⏰ Full Time

🟠 Senior

✍️ Designer

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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