Lead Clinical Data Manager

Responsibilities:Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports.Manage high complex studies and support specific activities of studies managed by other data managers or consultantsProvide technical tutoring and supervise data managers and/or contractors assigned to clinical studies by conducting regular reviews of activity statusIn-depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml)Manage and guide providers, setting requirements, preparing or reviewing Request for Proposals and monitoring 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 resultsEnsure all data collection systems for assigned projects are setup, tested and fit for purpose according to expectations and timelinesDefine the strategy and lead the preparation of data package for regulatory submissionRepresent data management for auditing and regulatory inspectionEHR data, data collected directly from patients, omics data, other secondary data)Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources.Requirements:Minimum 8+ years of experience in Clinical Data Management in CROs or Pharmaceutical IndustrySolid knowledge of drug development processesStrong data management expertiseExcellent knowledge of Good Clinical Data practices, GCP and regulatory requirementsExperience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors to collect data directly from patientsExcellent knowledge of Risk-Based approachKnowledge of Real-World data sources and processes to collect/manage different types of sources.Basic knowledge of Artificial Intelligence (AI)Project Management skillsExcellence in planning and priorities settingAnalytical, problem-solving skills and ability to take ownership of decision-makingStrong commitment to qualityExcellent oral and written communication and presentation skillsAbility to collaborate and work in a team-based environmentCourage, resilience, and ability to adjust to a rapidly changing environmentExperience with Medidata platformFamiliarity with other platforms for secondary dataProficiency in SAS Systems.