Clinical Data Management Consultant

Dale WorkForce Solutions; Thousand Oaks (CA); Remote; USD 90,000 - 130,000; Full time

Job summary

Dale WorkForce Solutions seeks a Clinical Data Management Consultant for a 1-year remote contract with a global biotech client. The role involves providing expertise in data management processes, developing best practices, and collaborating across teams to optimize clinical trial delivery. Ideal candidates will have extensive experience and a strong analytical skillset, with a focus on quality and compliance.

Qualifications

• Minimum of 10 years of experience in clinical data management.
• Knowledge of data visualization tools and statistical software.
• Experience in managing projects and implementing new processes.

Responsibilities

• Develop Data Management playbook and standard operating procedures.
• Analyze workflows and implement best practices in data management.
• Collaborate with clinical teams and lead on new technologies.

Skills

Problem Solving

Data Analysis

Communication

Education

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

EDC systems

CDISC standards

Tableau

Power BI

SAS

R

Job description

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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:

• 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)

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Biotechnology Research, Hospitals and Health Care, and Business Consulting and Services

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