The Principal Clinical Data Manager assists the Manager of Data Management in the oversight and execution of Data Management operations. Provides oversight for all data management operational activities in support of both clinical and non-clinical research studies from study build through study close. Mentors and trains Clinical Data Management staff.
- Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by management.
- Serve as a subject matter expert
- Participate in Business Development presentations and bid development
- Assigns tasks and responsibilities within Data Management to team members that optimizes team capacity, delivers of timely & accurate results, and supports the needs of the business.
- Provide mentoring and coaching to data management staff in daily operational activities
- Communicate with cross-functional groups and stakeholders throughout the project lifecycle
- Manage sponsor relationships and triage issues as appropriate
- Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
- Maintain Quality control of the clinical data, project deliverables, and closeouts
- Adhere to all aspects of SDC’s quality system
- Comply with SDC’s data integrity and business ethics requirements
- Perform other duties as assigned
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Exceptional working knowledge of clinical trials and the data management role
Excellent organizational and project management skills
Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
Able to work independently and in teams
Project management abilities including analytical evaluation, organization, flexible team management, negotiating and resource management skills
Excellent organizational and time management skills, with the ability to multi-task
Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
Strong interpersonal communication and presentation skills
Able to effectively collaborate across cross-functional teams
Education or Equivalent Experience
- Master’s Degree (preferably in engineering, applied or life science) and at least five (6) years of experience in clinical data management, or
- Bachelor’s degree (preferably in engineering, applied or life science) and work experience and at least seven
- Current Certified Clinical Data Manager (CCDM) status and at least seven (7) years of experience in clinical data management.
- (7) years of experience in clinical data management, or