Data Management Sr Mgr

Description:

Remote

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.

Job Description:

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:
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

Top 3 Must Have Skill Sets:

• Transformational Knowledge - large projects with changes (Pharma Background)
• Risk Based Quality Management Experience
• ICH E6 knowledge
• At least 10 years Mgt experience - need a Data Management background.
• Knowledge of working with Data Mgt teams in a remote environment.
• Veeva Knowledge is preferred.

Pay Rate open rate based on experience.

"This posting is for Contingent Worker, not an FTE"