Job Description

Position:

Clinical Data Management Consultant

Description:

Purpose: To provide expertise in data management processes, demonstrating capabilities and new ways of working, to assist in the design and implementation of both new technologies and processes.
Responsibilities include: Developing a Data Management playbook to establish key accountabilities; assessing and determining roles within the Data Management Team; identifying and implementing improvements based on ICH E6 (R3); collaborating with cross-functional teams to optimize trial delivery and ensure integration with risk-based approaches; developing and documenting standard operating procedures (SOPs); analyzing existing workflows and implementing best practices; suggesting data-driven improvements; planning and reviewing datasets; and evaluating and integrating new data management technologies. Ensure all data management activities comply with regulatory standards. Provide clear communication and leadership as a liaison across departments.

Requirements:

Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, external data collection like eCOA, Central Labs).
Experience in clinical data management or a related field (minimum of 10 years).
Familiarity with data visualization tools (Tableau, Power BI).
Knowledge of statistical software (SAS, R).
Strong problem-solving and analytical skills.
Project management and change management experience, including managing staff transitions between vendors.
Excellent written and verbal communication skills.
Knowledge and experience with risk-based approaches.
Relevant academic qualifications: Master's degree with 4 years experience, Bachelor's degree with 6 years experience, Associate's degree with 10 years experience, or High School diploma with 12 years experience.
Desired skills include experience with VEEVA and delivering complex technology implementations.

Benefits:

100% remote work from the US.
1-year contract with potential for extensions.
Market pay rate.
Opportunity to work for a global biotech company.
Exposure to leading technologies and process improvement.
Collaboration with cross-functional teams.
Hands-on experience with regulatory and technological advancements in clinical data management.

Job Tags

Remote job, Contract work,

Similar Jobs