Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – email@example.com
Job Description: The Principal Clinical Data Manager assists the Manager, 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, delivery 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 companys quality system
- Comply with company’s data integrity and business ethics requirements
- Perform other duties as assigned
- Adherence to all essential systems and processes that are required to maintain compliance to business and regulatory requirements
- 5+ years experience within Hematology is a must
- 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