Website Dale Workforce Solutions
Dale Workforce Solutions
Company : Dale Workforce Solutions
Client: global biotech company
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-GCP).
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