Senior Data Manager

GCD

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 controlTo ensure technologies/systems/data platforms needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integratedTo support the definition of the strategy for data submission and lead the preparation of the data package to be submitted for drug approvalTo 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 guidelinesTo provide data management input and revision to study protocolsTo design/review mock CRF/eCRF contents ensuring consistency with Study ProtocolTo manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performanceTo ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelinesTo review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation planTo collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conductionTo 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 reviewTo ensure data cleaning is performed by CROs in according to data validation specifications by the revision of appropriate listings or data quality checksTo review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implementedTo 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 IndicatorsTo lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reportsTo coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review statusTo ensure database are locked according to regulatory requirementsTo regular monitor data management costs of the assigned studies ensuring respect of budgetTo ensure audit readiness and involvement in the CAPA processTo lead the preparation of data package for regulatory submissionTo contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures

REQUIREMENTS AND SKILLS:

University Degree in Scientific DisciplinesMinimum 5 years of experience in Clinical Data Management in CROs or Pharmaceutical IndustryGood knowledge of drug development processesGood data management expertiseSolid knowledge of Good Clinical Data practices, GCP and regulatory requirementsExperience of clinical databases, electronic data capture (EDC) systems, Interactive Response System, ePatient Reported Outcome (ePRO), and wearables and sensors to collect data directly from patientsGood knowledge of Risk-Based approachKnowledge 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 (Define.xml)Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sourcesBasic knowledge of Artificial Intelligence (AI)English

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 IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

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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 https://jobs.iqvia.com