Clinical Data Manager (Contract)

Job Summary

Experienced Clinical Data Manager with expertise in the review and reporting of clinical data throughout the entire data lifecycle. Proven track record of developing comprehensive study documentation, designing, implementing, and managing data deliverables from start-up to closeout in adherence to industry standards and regulatory requirements. Skilled in fostering collaboration among clinical operations, biostatistics, and programming teams to integrate data management activities and enhance operational efficiency. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Responsibilities

• Acts as support for primary DM representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope

• Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management

• Define specifications and collaborate with technical team on configuration of elluminate for data cleaning strategy and oversight activities

• Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate modules

• Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks, and develop mitigation strategies

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, and reports for process and efficiency improvement

• Other duties as assigned

  Qualifications

• 5+ years experience in Clinical Data Management preferred

• Bachelor s degree in a health-related field or equivalent experience preferred

• CCDM Certification preferred

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills

• Excellent collaboration skills

• Demonstrated command of the English language with proficiency in both verbal and written communication

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)

• Experience with data reporting tools such as Qlik, JReview, Spotfire preferred

• Experience with RBQM methodology preferred

• Exposure to CDISC guidelines and standards

  AI Use Statement

Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment-not replace-professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.