Note: The job is a remote job and is open to candidates in USA. Emmes Group is a clinical research organization and technology company focused on advancing healthcare through clinical research, data, and analytical solutions. The Principal Clinical Data Manager provides leadership and subject matter expertise across the clinical data management lifecycle, overseeing data collection, electronic databases, validation, reconciliation, and data quality. The role also mentors data management staff and collaborates with internal and external cross-functional teams.
Responsibilities
- Serves as lead point of contact for both 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 strong technical knowledge, protocol specific information, and departmental standards. Ensures timely development and implementation of CRFs. Serves as 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/risks and recommending/implementing solutions
- Approves/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 data management team to ensure accuracy and consistency and creates corrective action plan as necessary
- Provides oversight of training documentation and system user access, may serve as resource for complex troubleshooting
- Mentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasks
- Authors, reviews, and/or edits written summaries of data reports, presents data as applicable
- Corporate Confidential:
- Provides oversight for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
- May be required to 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, providing recommendations for corrective action when necessary
- May provide direct line support for DM 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 DM salary and bonus equity compliance
- Approves timesheets, expense reports, and leave requests
- Performs other duties as assigned
- Complies with all policies and standards
Skills
- * Bachelor's Degree in scientific discipline preferred with a working knowledge of the clinical/scientific terminology and methods. Required
- * 7-9 years data management Required
- * Strong knowledge of clinical trial design, adaptive designs, survival analysis, and other advanced methods. High
- * Advanced knowledge of clinical data management principles, EDC systems, and CRF design. High
- * Strong analytical and problem solving skills to identify and resolve complex data issues. High
- * Leadership and mentorship capabilities to guide and develop data management staff. High
- * Excellent written and verbal communication skills for cross functional collaboration and reporting. High
- * Ability to manage multiple projects and priorities with strong organizational skills. High
- * Knowledge of regulatory standards, GCP, and data quality assurance practices. High
- * Proficiency in reviewing, developing, and implementing data validation and reconciliation processes. High
- * 4-6 years MS in scientific discipline accompanied with basic understanding of the clinical development Preferred
- * 7-9 years data management processes with 6 years progressive experience working in a clinical research environment Preferred
Company Overview
Company H1B Sponsorship