Data manager serp_jobs.h1.location_city

Payrate : $ - $

Responsibilities :

• 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 E (R), 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 , 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 (, 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 (, 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.

Requirements :

Experience :

Basic Qualifications :

Pay Transparency : The typical base pay for this role across the is : $ - $ Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, paid days off, (k) plan participation, commuter benefits and life and disability insurance.

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