Description:

Remote – U.S. (any time zone)
Schedule: Monday–Friday, 8:00 AM – 5:00 PM
Pay Rate: Open Market Rate

Join a large biotech pharmaceutical leader as a Clinical Data Management Transformation Lead. This role provides expertise in data management processes, driving new ways of working to support process redesign, technology implementation, and regulatory compliance. The successful candidate will bring deep domain expertise, strong leadership, and a proven track record in managing complex, transformational projects within clinical data management.
 

Responsibilities:

• Clinical Trial Delivery Operating Model

  • Develop a Data Management playbook defining accountabilities across study teams

  • Assess and optimize roles/responsibilities within Data Management

  • Redesign processes in line with ICH E6 (R3), using technology to reduce inefficiencies

  • Collaborate with clinical operations, site management, biostatistics, and other functions to optimize trial delivery

  • Apply risk-based approaches to trial delivery (e.g., reduced SDV)

  • Develop/document SOPs for data management activities

• Process Improvement

  • Analyze workflows and identify bottlenecks

  • Implement best practices for data collection, cleaning, and reporting (e.g., Pinnacle 21, Centralized Statistical Monitoring, RBQM)

  • Define KPIs and implement data-driven improvements

  • Ensure delivery of fit-for-purpose datasets aligned to analysis needs

• New Technology Design & Implementation

  • Evaluate and implement new tools (EDC systems, integration platforms, data flow)

  • Contribute to system design and user acceptance testing

  • Champion adoption of new technologies across teams

• Regulatory Compliance & Quality Assurance

  • Ensure compliance with FDA, EMA, and ICH-GCP requirements

• Cross-Functional Collaboration

  • Partner with senior leaders across development operations, statistics, quality, and IT

  • Act as liaison and SME across functional groups to align on strategy and execution

  • Contribute to design sessions, workshops, and leadership updates
     

Core Competencies:

• Technical expertise in data management standards (CDISC, eCOA, Central Labs)

• Analytical skills to interpret regulatory requirements and optimize processes

• Strong communication skills to present complex concepts to executive audiences

• Proven project management experience with budget and resource oversight

• Experience leading vendor transitions and remote teams
   

Top 3 Must Have Skills:

1. Deep expertise in clinical data management and systems (10+ years)

2. Risk-Based Quality Management and ICH E6 (R3) knowledge

3. Proven leadership in large, transformational projects within pharma/biotech

Basic Qualifications:

• Doctorate degree and 2 years of experience, OR

• Master’s degree and 4 years of experience, OR

• Bachelor’s degree and 6 years of experience, OR

• Associate’s degree and 10 years of experience, OR

• High school diploma/GED and 12 years of experience
   

Experience & Knowledge Requirements:

• Minimum 10 years in clinical data management or related field

• Proven leadership in complex process improvement initiatives

• Experience implementing new data management technologies

• Expertise with EDC systems (e.g., Veeva, Medidata)

• Knowledge of visualization tools (e.g., Tableau, Power BI) and statistical software (SAS, R)

• Risk-based quality management experience (e.g., reduced SDV trials)

• Strong track record in project/change management across global teams
   

"This posting is for Contingent Worker, not an FTE"