- Oversee a team of Clinical Data Managers.
- Manage each project assigned to the team.
- Perform quality control for each deliverable before sending to internal or external clients.
- Prepare and present individual performance reviews.
- Mentor staff and suggest and implement solutions for complex issues.
- Assist staff with interactions with sponsors and managing vendors.
- Keep supervisors 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 and study-specific training for the CDM and study teams.
- Provide input from the data management perspective regarding the design of clinical trial protocols.
- 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.
- Participate in the coding of medical terms.
- Define and perform SAE reconciliation processes.
- Work with DM leads and database programmers to design (e)CRFs and edit checks in the 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.
- Prepare training materials and user guides for EDC data collection tools and 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 and identify project scope changes when necessary.
- Present at sales and marketing meetings for prospective clients.
- Provide strategic input to the department and company goals.
- Lead key departmental goals and initiatives.
- 10+ years of experience in Clinical Data Management
- Minimum of 2 years of supervisory experience is required
- BS in a scientific or health-related field
- Knowledge of GCPs and regulatory agency guidelines
- Familiarity with medical terminology
- 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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Manager, Clinical Data Management - Boston, United States - Bayside Solutions
Description
Manager, Clinical Data Management
Direct Hire Full-Time Role
Salary Range: $154,000 - $175,000 per year
Location: Boston, MA - Hybrid or Remote
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Clinical Data Management, GCPs, regulatory, Medidata RAVE
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