Study Data Manager

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.The Study Data Manager is responsible for developing and implementing Data-Management planning for specific studies, for ensuring that the activities are completed according to agreed standards and timelines and for coordinating ongoing data management to support the flawless conduct of a clinical trial, by acting as representative in the study team.Primary contact between CDM and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding,CRF design, SSD, PM, DMS) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a studyParticipates in the development of protocols, CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.Coordinates CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies.Continually evaluates CDM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives.
Major Challenges:High quality CRFs designed to capture necessary data in support of a protocol's aims (with clinical team, including biostatistics, as well as CDM standards and quality group, programmers, coding officers). Highly detailed and appropriate Data Management Plan, including data validation plan, according to sanofi-aventis SOPs, that supports the most efficient management of CDM activities related to a clinical trial (with clinical team, including biostatistics, as well as other CDM support groups). Aggressive timelines managed effectively through cross-functional planning and cooperation (with clinical teams, including biostatistics, programmers, coders, others).
REQUIREMENTS
Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred. Expert in the use of Data Management applications and database/file structures; able to use SQL, SAS and other programming/query languages; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and resultsBachelor degree, preferably in a life science or mathematics-related area (e.g., computer sciencecs) or equivalent experience(at least 5 years) in clinical data management.Oral and written English communication skills.