Senior Quality Review Specialist

Role Overview

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
• Provide leadership to CDM team
• Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues
• Provide marketing capabilities presentations and business development presentations
• Serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task
• Serve as back-up for Data Operations Coordinator or Data Team Lead
• Provide leadership to Operations team
• Provide technical expertise
• Manage delivery of projects through full data management process life-cycle
• Management of project timelines, quality issues, resource management, SOW (scope of work) / budget
• Provide justification for customer negotiations
• May serve as Project Manager for single service data management projects
• Manage comprehensive data management tasks pertaining to the documented project specifications
• Manage comprehensive quality control procedures
• Provide data management expertise and data management process improvement to CDM management
• Mentor other team members in training and developing data management expertise
• Independently bring project solutions to the CDM team and the CDM Department
• Manage a focus team or a best practice team
• Manage the development and implementation of new technology/tool
• Present at professional conferences and/or publish articles in professional journals
• Provide CDM with technical expertise
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions
• Perform other duties as directed by the functional manager
• Meet objectives as assigned
• Develop and maintain good communications and working relationships with CDM and project teams.

Requirements

• Bachelor's Degree in clinical, biological or mathematical sciences, or related field or nursing qualification
• 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients, and including experience handling customer negotiations (e.g. bid defense meetings)
• Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology)
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Excellent experience and organizational, communication, and demonstrated expert data management skills
• Comprehensive understanding of clinical drug development process (detail oriented)
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Benefits

• None specified