What are the responsibilities and job description for the Manager, Clinical Data Management position at IntePros?
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
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.
- Bachelor's degree in a scientific or health-related field or equivalent qualification.
- Minimum of 10 years' experience in Clinical Data Management.
- Minimum of 2 years' supervisory experience required.
- 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.
