Job Description

Job Description

Job Description

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

RESPONSIBILITIES

Complete Data Management tasks for assigned studies under supervision according to the study contract and applicable SOPs

• Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
• Work with DB programmers to design (e)CRFs and edit checks in EDC system
• Develop test scripts and test data for User Acceptance Testing (UAT)
• Perform and document database and report UAT
• Receive, integrate, and reconcile electronic data
• Perform data review via listings and EDC system, issue and resolve queries
• Manage queries to ensure data completeness and integrity
• Review medical coding listings
• Assist with data listing design for data review
• Perform SAE reconciliation
• Perform pre-lock and data lock tasks
• Prepare training materials and user guides for EDC data collection tools
• Participate in client and team meetings as required
• Design, generate, and review status metric reports as needed
• Perform archiving of study databases and related documents
• Provide input to timelines to ensure timely completion of assigned tasks
• Provide regular status updates, keep the team and management informed of any changes
• Organize and file study documentation
• Work with management and senior DM personnel to implement technical solutions and resolve issues
• May lead small complexity projects

EDUCATION

• Minimum BS in a scientific or health related field or equivalent

EXPERIENCE

• Minimum 2 years of experience in Clinical Data Management.

SKILLS

• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio.
• Excellent communication and time management skills.

PHYSICAL REQUIREMENTS

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.

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