Clinical Data Manager

Summary

Prevail InfoWorks focuses on eClinical technology products including Clinical Data Integration, Clinical/Operational Risk-Based Data Analytics and Dashboards, eDC, eTMF, Safety System, IxRS/RTSM, CTMS, Investigator Grant Management and Clinical Budget Management. We provide these products in a SaaS model with world-class delivery, support and related clinical operations services.

The Philadelphia based company has a 15+ year track record of exceeding expectations and earning repeat business with its global biotech, biopharma, device and diagnostics customer base.

We are expanding our Clinical Data Management team with people who have drive, creativity, self-motivation, and professionalism. We are seeking Clinical Data Managers with a minimum of ten years’ experience.

Job Responsibilities and Requirements

• Define eCRF specs from a protocol
• Build eCRFs in EDC
• Define and build data set specs
• Define edit checks/validation specs
• Write and execute data management plans
• Clean and query data, and manage site/CRA follow up
• Manage reconciliations with external data such as labs and IRT
• Define listings and repots for technical staff in terms of clinical data set variables
• Provides directions and support activities for other Data Managers
• Other activities assigned by Director, Information Data Management

Requirements

• degree preferably in the sciences
• of ten years’ experience in clinical research as a Clinical Data Manager
• communications skills, both verbal and written, remotely and in-person
• and detail-oriented for improving data management processes
• to work as a team for organizational success

Education and Experience

Bachelor’s degree. Experience in clinical research, biotechnology and/or healthcare industry required. Experience with one or more of the following eClinical product areas: Data Integrations, Data Analytics, eDC, Safety, eTMF, RTSM/IxRS, CTMS, or Investigator Grant Management. Proficiency with Microsoft Office Tools (Excel-Spreadsheets, Word, PowerPoint).

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.