Manager, Clinical Data Management

Manager, Clinical Data Management

Client Overview:

Our client is a renowned full-service clinical research organization (CRO) recognized for its expertise in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. With a deep commitment to advancing medical innovations, they serve a diverse clientele comprising national and international biopharmaceutical and medical device companies.

Responsibilities:

• Supervise and lead a team of Clinical Data Managers (CDMs).
• Oversee the execution of each project assigned to the team.
• Conduct quality checks on all deliverables before submission to internal or external stakeholders.
• Prepare and deliver individual performance evaluations.
• Provide mentorship to DM staff and devise solutions for complex issues.
• Support staff in their interactions with sponsors and management of vendors.
• Keep supervisors informed of study progress and team management through regular meetings.
• Cultivate a positive, proactive management approach and foster effective communication within the team.
• Develop and update data management SOPs and training manuals.
• Conduct data management and study-specific training for CDMs and study teams.
• Offer insights from a data management perspective during clinical trial protocol design.
• Oversee the creation and maintenance of study-specific documentation.
• Manage data review, query generation procedures, and medical term coding.
• Define and perform SAE reconciliation processes.
• Collaborate with DM leads and DB programmers to design (e)CRFs and edit checks in the EDC system.
• Ensure the completion of UAT for EDC system and modules.
• Supervise DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
• Review queries and trends to ensure data completeness and integrity.
• Develop training materials and user guides for EDC data collection tools and deliver user training.
• Participate in client and team meetings, offering insights on best practices.
• Provide input to cross-functional study timelines and resource requirements.
• Deliver regular status updates to cross-functional study teams, management, and sponsors.
• Implement technical solutions, introduce new tools, and drive process improvement strategies.
• Lead large and complex projects and identify project scope changes.
• Present at sales and marketing meetings for prospective clients.
• Offer strategic input to departmental and company goals.
• Lead key departmental goals and initiatives.

Education:

• Bachelor's degree in a scientific or health-related field or equivalent qualification.

Experience:

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

Skills:

• Proficiency in GCPs and regulatory agency guidelines.
• Familiarity with medical terminology.
• Expertise in data management software applications, particularly Medidata RAVE.
• Exceptional organizational and time management skills.
• Strong collaboration and leadership abilities.
• Excellent oral and written communication skills.
• Outstanding interpersonal skills.

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