Overview Lead Clinical Data Manager role at Katalyst CRO . Join to apply for the Lead Clinical Data Manager role at Katalyst CRO . Location: Phoenix, AZ (if specified in posting) – see job details for current location and posting date. Responsibilities Plan and drive the conduct of all Data Management activities for assigned project(s) ensuring a consistent approach across studies. Manage highly complex studies and support specific activities of studies managed by other data managers or consultants. Provide technical tutoring and supervise data managers and/or contractors assigned to clinical studies by conducting regular reviews of activity status. Manage and guide providers, set requirements, prepare or review Requests for Proposals and monitor performance. Regularly monitor data management costs of the assigned studies ensuring respect of budget. Define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results. Ensure all data collection systems for assigned projects are set up, tested and fit for purpose according to expectations and timelines. Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. Define the strategy and lead the preparation of data package for regulatory submission. Represent data management for auditing and regulatory inspection. EHR data, data collected directly from patients, omics data, and other secondary data. In-depth knowledge of CDISC standards relating to data (SDTM, Define.xml). Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources. Qualifications Minimum 10 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry. Solid knowledge of drug development processes. Strong data management expertise. Excellent knowledge of Good Clinical Data practices, GCP and regulatory requirements. Experience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors to collect data directly from patients. Excellent knowledge of Risk-Based approaches. Knowledge of Real-World data sources and processes to collect/manage different types of sources. Project management skills; excellence in planning and priority setting. Analytical, problem-solving skills and ability to take ownership of decision-making. Strong commitment to quality; excellent oral and written communication and presentation skills. Ability to collaborate and work in a team-based environment; courage and resilience; ability to adjust to a rapidly changing environment. Experience with Medidata platform; familiarity with other platforms for secondary data. Proficiency in SAS. #J-18808-Ljbffr Katalyst CRO
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