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Sr. Manager, Data Management

Remote, CA

Posted: 08/05/2025 Employment Type: Contract Job Category: Operations and Development Job Number: 4543

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.
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
Core Competencies:

Technical Expertise:
  • Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, External Data Collection, eg eCOA, Central Labs etc).
  • Familiarity with data visualization tools and data analysis techniques.
Analytical Skills:
  • Strong problem-solving skills with the ability to analyze complex data sets.
  • Ability to interpret regulatory requirements and translate them into actionable processes.
Project Management:
  • Experience in managing projects, ensuring timely delivery and adherence to budgets.
  • Skills in change management to effectively implement new processes and technologies.
  • Experience with managing projects involving staff transitions between vendors
Communication Skills:
  • Excellent verbal and written communication skills for effective collaboration.
  • 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)
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