Job title: Manager, Clinical Data Scientist, Clinical Data Sciences
Job description: Job Description : Why Patients Need You As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for t
Job Description : Why Patients Need You As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high-quality data management deliverables supporting the Pfizer portfolio. The 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 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.What You Will Achieve It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc. As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe. ROLE RESPONSIBILITIES Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting Partners with Research/Business Units, external DM service providers and internal DMM staff to deliver high quality data management for all studies as assigned. Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s). Ensure work carried out by or on behalf of DMM is in accordance with applicable SOPs and working practices. Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems. Ensure the required study specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release. QUALIFICATIONS Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review Strong Project and Risk Management CRO and vendor oversight experience preferred Strong verbal and written communication skills Consistent, detail oriented, communicative, dedicated to do a job well done Minimum 10 years Data Management experience required Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred) Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview) Familiarity with MedDRA/WHO-Drug Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical#LI-PFE
Location: Chennai, Tamil Nadu
Job date: Sun, 20 Mar 2022 23:04:57 GMT
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