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Manager, Data Management

Cambridge, MA 02140

Posted: 08/15/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 580402 Is job remote?: No Country: United States

Job Description

Manager, Data Management

RESPONSIBILITIES • Manage and supervise a team of Clinical Data Managers (CDMs) o Oversee each project assigned to the team
o QC each deliverable prior to sending to internal or external clients
o Prepare and present individual performance reviews
o Provide mentorship to DM staff and suggest/implement solutions for complex issues
o Assist staff with interactions with sponsors and managing vendors
o Keep supervisor updated on study progress and staff management through routine meetings
o 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
• A minimum of 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
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

Salary Range: $130-$150k. Salary will be commensurate with experience 
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