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 according to data validation specifications by the revision of appropriate listings or data quality checks To review database structure annotated CRF and 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 database are locked according to regulatory requirements To regular 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 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 Word data sources and processes to collect / manage different type 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 () Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources Basic knowledge of Artificial Intelligence (AI) TYPE OF CONTRACT : Maternity cover 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. Please enter the authorization for the processing of personal data (DL196 / 2003) - General Data Protection Regulation (13 GDPR 679 / 16 )to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903 / 77). LI-CES LI-DNP IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at Required Experience : Manager Key Skills SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills Employment Type : Full-Time Experience : years Vacancy : 1 J-18808-Ljbffr J-18808-Ljbffr