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

• Manage and supervise a team of Clinical Data Managers (CDMs)
• Oversee each project assigned to the team
• QC each deliverable prior to sending to internal or external clients
• Prepare and present individual performance reviews
• Provide mentorship to DM staff and suggest/implement solutions for complex issues
• Assist staff with interactions with sponsors and managing vendors
• Keep supervisor updated on study progress and staff management through routine meetings
• Maintain a positive, progressive, and proactive management style and communication
• Develop and update data management SOPs and training manuals
• Conduct data management training as well as study specific training for the CDM and study teams
• Provide input from the data management perspective regarding the design of clinical trial protocols
• Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
• Oversee and participate in the process of data review and query generation procedures
• Oversee and participate in the coding of medical terms
• Oversee/define/perform SAE reconciliation processes
• Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system
• Ensure proper completion of UAT of EDC system and modules
• Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
• Review queries and trends to ensure data completeness and integrity
• Review/prepare training materials and user guides for EDC data collection tools, deliver user training
• Participate in client and team meetings as required advising on best practices as appropriate
• Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
• Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
• Implement technical solutions, new tools, and process improvement strategies
• Lead large and complex projects
• Identification of project scope changes
• Present at sales and marketing meetings for prospective clients
• Provide strategic input to the department and company goals
• Lead key departmental goals and initiative

EDUCATION

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

EXPERIENCE

• Minimum of 10 years of experience in Clinical Data Management
• Minimum 2 years supervisory experience is required

SKILLS

• Knowledge of GCPs and regulatory agency guidelines
• Familiarity with medical terminology is required
• Skilled in the use of data management software application, Medidata RAVE
• Excellent organizational and time management skills
• Strong collaboration and leadership skills
• Excellent oral and written communication skills
• Strong interpersonal 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.