Clinical Data Manager II

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 all Data Management tasks from study start-up to database lock for assigned studies according to the applicable SOPs and study-specific procedures. Lead small to medium size studies. Effectively interact with sponsors and manage vendors. Provide input to departmental SOPs and design study-specific procedures:

• 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 for small to medium complexity studies
• Develop test scripts and test data for User Acceptance Testing (UAT)
• Coordinate eCRF screen and edit check UAT tasks for small to medium complexity studies
• Perform and document UAT, including database testing, data export testing, and testing of custom programming
• Receive, integrate, and reconcile electronic data
• Design study-specific processes for electronic data receipt and handling
• Perform and coordinate data review via listings and EDC system
• Manage query issue and resolution to ensure data completeness and integrity
• Review medical coding listings and provide input
• 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 and provide input
• Design, generate, and review status metric reports, as needed
• Perform archiving of study databases and related documents
• Organize and file study documentation
• Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones
• Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
• Provide study specific training for team members
• Implement technical solutions and resolve issues
• Lead small to medium complexity projects
• Delegate tasks as appropriate
• Interact with sponsors and manage vendors
• Assist with identification of project scope changes
• Assist with sales and marketing presentations
• Participate in departmental process improvements

EDUCATION

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

EXPERIENCE

• Minimum 3 years of experience in Clinical Data Management

SKILLS

• Knowledge of medical terminology and pharmaceutical notation
• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
• Excellent communication and time management skills
• Leadership 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.