Senior Data Management Specialist

3 weeks ago

Cambridge, Massachusetts, United States Innova Solutions Full time
About the Role

We are seeking a highly experienced and skilled Data Management Leader to join our team at Innova Solutions. As a Data Management Leader, you will be responsible for overseeing and managing a team of Clinical Data Managers, ensuring the delivery of high-quality data management services to our clients.

Key Responsibilities
  • Manage and supervise a team of Clinical Data Managers, providing guidance and support to ensure the successful delivery of projects.
  • Oversee each project assigned to the team, ensuring that deliverables are met and quality standards are maintained.
  • Prepare and present individual performance reviews, providing constructive feedback and coaching to team members.
  • Develop and update data management SOPs and training manuals, ensuring that team members have the necessary skills and knowledge to perform their roles effectively.
  • Conduct data management training and study-specific training for the CDM and study teams, ensuring that all team members are equipped to manage data effectively.
  • Provide input from the data management perspective regarding the design of clinical trial protocols, ensuring that data management considerations are taken into account.
  • 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, ensuring that data is accurate and complete.
  • Oversee and participate in the coding of medical terms, ensuring that data is accurately coded and classified.
  • Oversee/define/perform SAE reconciliation processes, ensuring that data is accurate and complete.
  • Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system, ensuring that data is accurately captured and validated.
  • Ensure proper completion of UAT of EDC system and modules, ensuring that data is accurately captured and validated.
  • Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation, ensuring that data is accurately captured and validated.
  • Review queries and trends to ensure data completeness and integrity, ensuring that data is accurate and complete.
  • Review/prepare training materials and user guides for EDC data collection tools, deliver user training, ensuring that team members have the necessary skills and knowledge to perform their roles effectively.
  • Participate in client and team meetings as required, advising on best practices as appropriate, ensuring that data management considerations are taken into account.
  • Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies, ensuring that data is accurately captured and validated.
  • Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes, ensuring that data is accurately captured and validated.
  • Implement technical solutions, new tools, and process improvement strategies, ensuring that data is accurately captured and validated.
  • Lead large and complex projects, ensuring that data is accurately captured and validated.
  • Identification of project scope changes, ensuring that data is accurately captured and validated.
  • Present at sales and marketing meetings for prospective clients, ensuring that data management considerations are taken into account.
  • Provide strategic input to the department and company goals, ensuring that data management considerations are taken into account.
  • Lead key departmental goals and initiative, ensuring that data management considerations are taken into account.
Requirements
  • Minimum BS in a scientific or health-related field or equivalent.
  • Minimum of 10 years of experience in Clinical Data Management.
  • Minimum 2 years supervisory experience is required.
  • 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.

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