Senior Clinical Database Designer

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Create new features and enhance functionality within the database design areas.

• Support Clinical Data Management in the planning, direction, and oversight of the clinical database design and maintenance process.

• Examine the protocol along with related study reference materials.

• Manage timelines for database design.

• Stay updated on regulatory requirements, industry trends, benchmarking, and best practices.

• Design and evaluate case report forms (CRFs/eCRFs).

• Write and review the Data Validation Specifications.

• Create and assess User Acceptance Test (UAT) plans.

• Coordinate and supervise the UAT process.

• Design and assess patient Case Report Forms and the database schema.

• Test data capture/entry screens during UAT.

• Take part in technical learning and exchange meetings with EDC vendors.

• Provide training to CRAs on EDC systems.

• Assist in the creation and upkeep of the company's database design procedural documentation.

• Plan, manage, oversee, and execute data processing tasks for assigned projects.

• Review the Data Management Plan (DMP).

• Scrutinize data, and address and resolve queries.

• Aid in rectifying medical coding discrepancies.

• Collaborate with the Quality Assurance Department on quality control audits.

• Define and supervise clinical trial data flow and quality control procedures.

• Validate electronically captured data accurately and efficiently.

• Formulate clear queries regarding missing data and data points that do not meet predefined range checks.

• Develop and test SAS codes for logical checks within the clinical trial database and for study-specific monitoring reports.

⛳️ Requirements

• Bachelor’s degree in Biological Sciences or Computer Science.

• Five years of relevant experience.

• Two to three years of experience developing Inform and/or Medidata Rave (or similar) clinical databases.

• Prior experience in Clinical Data Management with both paper-based and electronic data capture systems.

• Must be able to communicate effectively, both orally and in writing, with personnel across all professional and administrative levels.

• Demonstrated leadership and interpersonal skills in intricate team dynamics.

• Exceptional presentation skills and the ability to cultivate relationships with both internal and external clients.

• Must be highly organized and capable of working independently while managing multiple projects/tasks effectively.

• Proven ability to efficiently organize and integrate the efforts 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).

• 401(k) retirement plan.

• Generous paid time off.

• Sick leave.

• Opportunity to earn a performance-based bonus.