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As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development &amp; Operations (CD&amp;O) organization, the Manager, Senior Clinical Data Scientist (Sr CDS) is responsible for timely and high-quality data management deliverables supporting the Pfizer portfolio. The Sr CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The Sr CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Sr CDS may have one or more direct reports.ROLE RESPONSIBILITIES<ul><li>Serves as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.</li><li>May functionally manage a team of Associate Data Managers, Senior Data Managers, be responsible for resource allocation, training and development.</li><li>Works with Asset Leads to establish strategy, timelines, and adequate resourcing of DMs at Asset/Study level.</li><li>Ensures appropriate documentation across the lifespan of the study/asset for all DM deliverables and ensures the required study specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.</li><li>May likely be involved in development of TA specific standards.</li><li>Provides project management leadership to DM teams – Responsible for managing issues at the study level as they arise and proactively communicating to Asset Lead and Management while serving to provide solutions.</li><li>Acts as the key scientific and technical data management expert; contribute to department level initiatives and ensure effective reporting of study status and metrics to Management.</li><li>Ensures work carried out on behalf of CDIS is in accordance with applicable SOPs and working practices.</li><li>Serves as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.</li><li>May act as data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.</li></ul>QUALIFICATIONS<ul><li>Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.</li><li>Minimum 7 years Data Management experience required, including experience in team leadership.</li><li>Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting.</li><li>Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review.</li><li>Strong Project and Risk Management.</li><li>CRO and vendor oversight experience preferred.</li><li>Strong verbal and written communication skills.</li><li>Consistent, detail oriented, communicative, dedicated to do a job well done.</li><li>Knowledge of clinical research, FDA &amp; ICH, GCP, GCDMP, and related regulatory requirements.</li><li>Proficient experience using commercial clinical data management systems and/or EDC products (Medidata RAVE, Oracle RDC, Inform preferred).</li><li>Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview).</li><li>Strong knowledge of MedDRA/WHO-Drug.</li><li>Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).</li></ul>

Job Ads Human Resources Manager Νομός Θεσσαλονίκης, Healthcare Professions

manager, senior clinical data scientist 4952131

Pfizer Hellas

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