Principal Clinical Data Manager

Job Description

Principal Clinical Data Manager Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary 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. Primary Responsibilities 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 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. Required Skills Exceptional working knowledge of clinical trials and the data management role Excellent organizational and project management skills Expert knowledge and understanding of ICH Guid