Clinical Data Management Consultant
Job: Clinical Data Management Consultant
Location: 100% remote from the US
Duration: 1 year contract, open to extensions
Rate: market pay rate
Job Description:
Purpose: To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.
Clinical Trial Delivery Operating Model:
- Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team
- Assess and determine roles and responsibilities within the Data Management Team
- Cleansheet Data Management processes and identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs.
- Collaborate with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.
- Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally - consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an appropriate risk-based approach, eg. reduced SDV etc
- Develop and document standard operating procedures (SOPs) for data management activities
Process Improvement:
- Analyze existing workflows and identify bottlenecks with new ways of working
- Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.
- Determine key performance indicators (KPIs) and suggest data-driven improvements
- Delivering a quality, fit for purpose dataset - plan, build, review with the end in mind (protocol - data collection - data review - analysis - archive)
New Technology Design and Implementation:
- Evaluate new data management tools and technologies (e.g., EDC systems, data integration platforms, data flow).
- Participate in system design, and user acceptance testing.
- Role model with staff on new technologies and ensure smooth integration into new and/or modified processes
Regulatory Compliance and Quality Assurance:
- Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-Google Cloud Platform).
Cross-Functional Collaboration:
- Collaborate with clinical teams to ensure data collection aligns with study objectives.
- Serve as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.
Core Competencies:
Technical Expertise:
o Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, External Data Collection, eg eCOA, Central Labs etc).
o Familiarity with data visualization tools and data analysis techniques.
Analytical Skills:
o Strong problem-solving skills with the ability to analyze complex data sets.
o Ability to interpret regulatory requirements and translate them into actionable processes.
Project Management:
o Experience in managing projects, ensuring timely delivery and adherence to budgets.
o Skills in change management to effectively implement new processes and technologies.
o Experience with managing projects involving staff transitions between vendors
Communication Skills:
o Excellent verbal and written communication skills for effective collaboration.
o Ability to present complex data and concepts to diverse audiences.
Experience & Knowledge:
- Minimum of 10 years of experience in clinical data management or related field.
- Proven track record of leading delivering on complex process improvement initiatives
- Ideally proven track record of delivering on complex technology implementations.
- Familiarity with Electronic Data Capture (EDC) systems (e.g., Veeva, Medidata).
- Knowledge of data visualization tools (e.g., Tableau, Power BI).
- Knowledge in statistical software (e.g., SAS, R) for data analysis.
- Knowledge, and ideally experience, of working with risk-based approaches (e.g. delivering studies using reduced SDV etc)
Basic Qualifications:
- Master's degree and 4 years of experience
- Bachelor's degree and 6 years of experience
- Associate's degree and 10 years of experience
- High school diploma / GED and 12 years of experience
Job: Clinical Data Management Consultant
Location: 100% remote from the US
Duration: 1 year contract, open to extensions
Rate: market pay rate
Job Description:
Purpose: To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.
Clinical Trial Delivery Operating Model:
- Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team
- Assess and determine roles and responsibilities within the Data Management Team
- Cleansheet Data Management processes and identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs.
- Collaborate with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.
- Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally - consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an appropriate risk-based approach, eg. reduced SDV etc
- Develop and document standard operating procedures (SOPs) for data management activities
Process Improvement:
- Analyze existing workflows and identify bottlenecks with new ways of working
- Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.
- Determine key performance indicators (KPIs) and suggest data-driven improvements
- Delivering a quality, fit for purpose dataset - plan, build, review with the end in mind (protocol - data collection - data review - analysis - archive)
New Technology Design and Implementation:
- Evaluate new data management tools and technologies (e.g., EDC systems, data integration platforms, data flow).
- Participate in system design, and user acceptance testing.
- Role model with staff on new technologies and ensure smooth integration into new and/or modified processes
Regulatory Compliance and Quality Assurance:
- Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-Google Cloud Platform).
Cross-Functional Collaboration:
- Collaborate with clinical teams to ensure data collection aligns with study objectives.
- Serve as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.
Core Competencies:
Technical Expertise:
o Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, External Data Collection, eg eCOA, Central Labs etc).
o Familiarity with data visualization tools and data analysis techniques.
Analytical Skills:
o Strong problem-solving skills with the ability to analyze complex data sets.
o Ability to interpret regulatory requirements and translate them into actionable processes.
Project Management:
o Experience in managing projects, ensuring timely delivery and adherence to budgets.
o Skills in change management to effectively implement new processes and technologies.
o Experience with managing projects involving staff transitions between vendors
Communication Skills:
o Excellent verbal and written communication skills for effective collaboration.
o Ability to present complex data and concepts to diverse audiences.
Experience & Knowledge:
- Minimum of 10 years of experience in clinical data management or related field.
- Proven track record of leading delivering on complex process improvement initiatives
- Ideally proven track record of delivering on complex technology implementations.
- Familiarity with Electronic Data Capture (EDC) systems (e.g., Veeva, Medidata).
- Knowledge of data visualization tools (e.g., Tableau, Power BI).
- Knowledge in statistical software (e.g., SAS, R) for data analysis.
- Knowledge, and ideally experience, of working with risk-based approaches (e.g. delivering studies using reduced SDV etc)
Basic Qualifications:
- Master's degree and 4 years of experience
- Bachelor's degree and 6 years of experience
- Associate's degree and 10 years of experience
- High school diploma / GED and 12 years of experience