Job title: Senior Associate, Senior Data Manager, Clinical Data Sciences
Job description: Job Description : ROLE SUMMARY As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Data Manager is responsible for timely and high-quality da
Job Description : ROLE SUMMARY As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Data Manager is responsible for timely and high-quality data review and query management of clinical data supporting the Pfizer portfolio. The Senior Data Manager develops and maintainskey data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.What You Will Achieve It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans, including data preparation and validation activities, among others. As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams. It is your commitment and hard work that will help make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It Serve as Lead Data Manager for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities. Independently lead the daily DM activities and allocate study DM resource in the appropriate way. Coach junior Data Managers in the study and perform peer review of study DM’s deliverables for quality control. Be responsible to achieve the study DM milestone on time with good quality. In collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables. Ensure work carried out in accordance with applicable SOPs and working practices. Ensure the required study specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities. Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities. Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross study learning. Be capable to contribute on the DM related continuous improvement activities Qualifications Must-Have Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP Demonstrated knowledge of data management processes and principles in area of responsibility. Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review Demonstrates strong verbal and written communication skills including ability to communicate remotely Minimum 7 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 (e.g., Inform preferred) Experience using data visualization tools (e.g. Spotfire, J-Review) preferred Familiarity with MedDRA/WHO-Drug Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Bachelor’s degree minimum requirement. Experience of project management skill in terms of resource management and timeline and quality control preferred. Nice-to-Have Master’s degree Relevant pharmaceutical industry experience Experience using data visualization tools Proficient experience using commercial clinical data management systems and/or EDC products Awareness of regulatory requirements and relevant data standards 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: Mon, 14 Mar 2022 23:55:45 GMT
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