On behalf of our Client, a global pharmaceutical company, IQVIA is looking for a Senior Data Manager who can join an exciting working environment in a dynamic atmosphere.
JOB DESCRIPTION: To ensure data management activity of the assigned studies are planned and executed according to project timelines, with highest standards in data integrity, data quality and under budget control. To ensure technologies/systems/data platforms needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integrated. To support the definition of the strategy for data submission and lead the preparation of the data package to be submitted for drug approval. To represent Data Management in case of audit and Regulatory Inspection. RESPONSIBILITIES: To plan and drive the conduct of all Data Management activities for the assigned studies ensuring consistency with Company standards and regulatory guidelines. To provide data management input and revision to study protocols. To design/review mock CRF/eCRF contents ensuring consistency with Study Protocol. To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance. To ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelines. To review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation plan. To collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conduction. To train or to provide consultancy to internal stakeholders on data management processes/standards/usage of tools (i.e. UAT, EDC tools, etc.). To assist coding of medical terms and medical review. To ensure data cleaning is performed by CROs in accordance with data validation specifications by the revision of appropriate listings or data quality checks. To review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implemented. To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results, including contribution of definition of Quality Tolerance Limits and Key Risks Indicators. To lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. To coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review status. To ensure databases are locked according to regulatory requirements. To regularly monitor data management costs of the assigned studies ensuring respect of budget. To ensure audit readiness and involvement in the CAPA process. To lead the preparation of data package for regulatory submission. To contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures. REQUIREMENTS AND SKILLS: University Degree in Scientific Disciplines. Minimum 5 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry. Good knowledge of drug development processes. Good data management expertise. Solid knowledge of Good Clinical Data practices, GCP and regulatory requirements. Experience of clinical databases, electronic data capture (EDC) systems, Interactive Response System, ePatient Reported Outcome (ePRO), and wearables and sensors to collect data directly from patients. Good knowledge of Risk-Based approach. Knowledge of Real World data sources and processes to collect/manage different types of sources (e.g. EHR data, data collected directly from patients, omics data, other secondary data). In-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). Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources. Basic knowledge of Artificial Intelligence (AI). English proficiency. TYPE OF CONTRACT: Long Term contract – Staff Leasing.
IQVIA reserves the right to evaluate candidates with domicile/residence and work experience/study with requirements responding to the open request. Applications WITHOUT the requirements will NOT be fully taken into account.
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