ADVANCED BIO-LOGIC SOLUTIONS
Data Management Sr Mgr
ADVANCED BIO-LOGIC SOLUTIONS, Thousand Oaks, California, United States, 91362
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:
Deep expertise in clinical data management and systems (10+ years)
Risk-Based Quality Management and ICH E6 (R3) knowledge
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"
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:
Deep expertise in clinical data management and systems (10+ years)
Risk-Based Quality Management and ICH E6 (R3) knowledge
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"