Verified Job On Employer Career Site Job Summary: Dale WorkForce Solutions is looking for a Data Management Senior Manager to provide expertise in data management processes and assist in the design and implementation of new technologies and processes. The role involves developing a Data Management playbook, collaborating with cross-functional teams, and ensuring compliance with regulatory standards while driving process improvement initiatives. Responsibilities: • 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 • 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) • 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 • Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-GCP). • 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. Qualifications: Required: • 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). • Doctorate degree and 2 years of experience OR Masters degree and 4 years of experience OR Bachelors degree and 6 years of experience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years of experience. • 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 change 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. Preferred: • Veeva Knowledge Is Preferred. • Transformational Knowledge large projects with changes (Pharma Background). • Risk Based Quality Management Experience. • ICH E6 knowledge. • Knowledge of working with Data Mgt teams in a remote environment. Company: Dale Workforce Solutions is a staffing and talent solution firm that provides staffing, on-demand consultation and payroll services. Founded in 2012, the company is headquartered in New York, New York, USA, with a team of 11-50 employees. The company is currently Early Stage.