Principal Clinical Data Manager

Role Overview

• Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program
• Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM
• Manage system integrations across data platforms
• Ensure CRO and third-party data review outputs are reviewed according to agreed plans and filed in the Trial Master Plan as appropriate
• Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs
• Review data for protocol deviation identification, dictionary coding, and perform user acceptance testing of database
• Review documents produced by vendors and other departments
• Create data management process documents such as data management plans, data review specifications, data transfer agreements, diagram workflows, timelines and communication plans
• Work cross-functionally with other departments within the company assessing and understanding their needs
• Strategize and plan for database locks and multiple deliverables across numerous studies within a program ensuring consistency in process
• Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective
• Provide guidance to clinical data management personnel on assigned projects
• Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.)
• Independently monitor own activities and project status for successful project deliverables according to timelines
• Adhere to budgets and timelines
• Ensure project is in reasonable state of inspection readiness and compliance

Requirements

• Bachelor’s degree in life science, pharmacy or related field
• Equivalent combination of education and applicable job experience may be considered
• 6 years of direct Data Management experience required
• Prior clinical trial vendor management and integration experience a must
• Demonstrated knowledge of drug development and Clinical Data Management processes
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Understanding of ICH Guidelines and GCP Requirements
• Excellent communication skills and interpersonal skills
• Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE
• Experience in managing outsourced studies and/or leading CRO data management teams
• Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing and vendor reconciliation
• Experience in solving complex and increasingly difficult problems
• Ability to leverage Artificial Intelligence Models to support evolving data efficiencies is preferred
• Ability to develop and maintain timelines
• Understanding of dictionary coding (i.e. MedDRA and WHODrug)
• Self-motivated and can independently manage responsibilities with minimal supervision
• Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets)
• Ability to travel as necessary (approximately 10%)

Tech Stack

• Google Cloud Platform

Benefits

• premium health
• financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off