Payrate: $55.00 - $60.00/hr. Job Duties: 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 determines roles and responsibilities within the Data Management Team Clean sheet 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 Skills: 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. Strong problem-solving skills with the ability to analyze complex data sets. Ability to interpret regulatory requirements and translate them into actionable processes. Experience in managing projects, ensuring timely delivery and adherence to budgets. Skills in changing management to effectively implement new processes and technologies. Experience with managing projects involving staff transitions between vendors 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 delivery 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) Pay Transparency: The typical base pay for this role across the U.S. is: $55.00 - $60.00 /hr. 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, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology, including calls from an AI Voice Recruiter. #AditiConsulting Aditi Consulting
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