Principal Clinical Data Manager

About the role

This is an evergreen position intended to help identify and engage with talented professionals for potential future hiring needs. While there may not be an immediate opening or approved requisition associated with this posting, qualified applicants may be contacted should a suitable opportunity become available.

The Principal Clinical Data Manager provides data management leadership and subject matter expertise for research studies. The role works as an integral part of a cross-functional team throughout the lifecycle of the research study—from design through final analysis and study closeout. The Principal Clinical Data Manager is responsible for the completeness and accuracy of study data in the electronic database and serves as an expert consultant to internal and external teams on all aspects of data collection and data management best practices.

Responsibilities

• Serves as the lead point of contact for internal cross-functional teams and external contacts on the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system.
• Provides oversight for creation and/or review of study-specific electronic or paper case report forms (CRFs) using technical knowledge, protocol-specific information, and departmental standards; ensures timely development and implementation of CRFs.
• Serves as a project or therapeutic area resource for design and development challenges.
• Provides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive system experience to drive development.
• Responsible for analyzing potential complex data management issues and risks and recommending and implementing solutions.
• Approves and/or reviews clinical data management plans or develops key study document templates (e.g., Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents).
• Leads data reviews with the data management team to ensure accuracy and consistency and creates corrective action plans as necessary.
• Provides oversight of training documentation and system user access; may serve as a resource for complex troubleshooting.
• Mentors data management staff in general team leadership skills, project management skills, internal Emmes data management processes, and project- or therapeutic-area-specific tasks.
• Authors, reviews, and/or edits written summaries of data reports and presents data as applicable.
• Provides oversight for the management and reconciliation processes of data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources.
• May facilitate or present at meetings, conferences, and other events representing Emmes, including job fairs or other external events.
• Develops and implements data validation processes; ensures the integrity of data and provides recommendations for corrective action when necessary.
• May provide direct line support for data management staff.
• For direct reports:
  • Collaboratively conducts performance and compensation review activities with the applicable project leader or designee.
  • Responsible for addressing employee relations issues and resolving problems.
  • Ensures data management salary and bonus equity compliance.
  • Approves timesheets, expense reports, and leave requests.
• Performs other duties as assigned and complies with all policies and standards.

Qualifications

• Bachelor’s degree in a scientific discipline preferred with a working knowledge of clinical/scientific terminology and methods.
• 7–9 years of data management experience required.
• 4–6 years of Master’s degree in a scientific discipline accompanied by a basic understanding of clinical development preferred.
• 7–9 years of data management processes with 6 years of progressive experience working in a clinical research environment preferred.
• Strong knowledge of clinical trial design, adaptive designs, survival analysis, and other advanced methods.
• Advanced knowledge of clinical data management principles, EDC systems, and CRF design.
• Strong analytical and problem-solving skills to identify and resolve complex data issues.
• Leadership and mentorship capabilities to guide and develop data management staff.
• Excellent written and verbal communication skills for cross-functional collaboration and reporting.
• Ability to manage multiple projects and priorities with strong organizational skills.
• Knowledge of regulatory standards, GCP, and data quality assurance practices.
• Proficiency in reviewing, developing, and implementing data validation and reconciliation processes.