Manager, Clinical Data / 08-5053

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

The Clinical Data Manager (DMG) is responsible for managing Clinical Data Management (CDM) activities in accordance with project timelines and operating procedures ensuring compliance with regulations as well as GCPs. Key trial activities for internal projects include planning and approving database design as well as managing clinical data through project life cycle through database clean and lock. For outsourced trials, the DMG provides supervision, monitors deliverable quality and approves major milestones. The DMG is responsible for representing CDM both internally and externally and for analyzing current operating techniques in order to insure optimal usage. The technical/functional environment is the CDM platform, operating through a Clinical Data Management System (CDMS), within the Clinical Operations group of the Clinical department. The DMG reports to the Deputy Director, Clinical Data Managers - North America for appraisal and training and is accountable to Clinical Team Leaders for clinical project issues. The DMG represents CDM on Clinical Teams, works with other CDM staff to ensure consistency of operating practices and works with Clinical Team Leaders and/or Clinical Coordinators to evaluate the necessary CDM resources needed to meet expected project timelines. Monitors project timelines and works with Clinical Operation staff to assist with evaluating the necessary CDM resources needed to meet expected project timelines. Assists with implementation of CDM strategies to meet expected project related goals. Organizes methods to meet timelines and assure quality output. Identifies potential difficulties in reaching project timelines and offers solutions to resolve any difficulties that may deter project goals.Provides guidance and assistance to clinical team members for problem resolution.Ensures all operational aspects needed for CDM are achieved to perform functional tasks, including data capture, encoding, cleaning and database lock.Researches potential improvements to operating procedures for the platform and advancements in CDM. Works with counterparts based at other sites to implement necessary changes and improvement for the platform.Supports and aids in the design of databases for clinical studies performed in-house. Assists with testing of clinical databases to ensure functionality. Performs and documents validation procedures and edits.Provides locked clinical databases (i.e. SAS datasets) for statistical analysis within timelines requested.We are an equal opportunity employer. M/F/D/V

Qualifications:

Degree or Diploma in Health/Life Sciences or other related area5 years experience in data management in clinical/medical fieldWorking knowledge of data management software and computing skills