Database Standard and Design Senior Specialist

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.Define and support worldwide management of all metadata for Clintrial, Oracle/Clinical, and any other systems used to capture and manage all clinical study data including:
Standard database design metadata and all related libraries (panels, items, codelists, derived items, screens).
Standard database program-related metadata components (rules, derivations, conversion procedures, edit checks, packages and functions).Duties and Responsibilities
Develop and/or collaborate in the development/updating of user guides, standard documentation, FAQs, training materials and other documentation to support understanding and consistent usage of established standards.
Provide study database design services, including but not limited to assistance with edit check programming and/or set-up, to Study Database Managers as needed.
Provide services in support of external data loading or data transfers as needed.
Ensure that Study Database Managers use and understand established standards.
Perform quality/consistency checks on newly designed databases; solved any detected issues; distribute approved databases into production instances.
Serve as CDMS application "super-users". Activities may include: mentoring junior users, delivering training, helping to diagnose/solved problems if called upon by the Systems Operation & Development groups, user testing of relevant software patches/upgrades, participation in enhancement and/or new system development efforts and other activities requiring the skills/experience of user experts.
Work closely with System Operation & Development groups and others, representing the interests of DSD during the development new/enhanced CDMS applications and related documentation.
Work closely with all the TA groups to understand, plan, help and satisfy their needs during the implementation of the clinical studies.Key Internal/External Relationships
Reporting relationship to NA Site Manager, DSD. If physically located in an office different from the functional leaders, this position will also report administratively to the local DM Site Head.
Work closely with TA, Project, and Study level Data Managers to support and satisfy the study design and programming needs.
Work closely with other GQSM sub-groups to ensure consistency of standards across CRFs, Database metadata, and supporting codelists and to support achievement of GQSM group goals.
Work closely with the Systems and Programming group, participating in projects where there is an impact on database design or standards.
REQUIREMENTS
Knowledge and Skills
Advanced expertise in clinical study database design and metadata validation.
High degree of proficiency with Oracle and PL/SQL programming including ability to develop PL/SQL packages and functions.
Excellent analytical skills.
Strong oral and written communication skills.
SAS programming expertise is a plus.
Prior database design and general user training with standard clinical data management software.
Prior training on CDISC SDTM, ODM, or AdaM data models are a plus.
Oracle DBA Certification is a plus.
Fluent English is required. Reading/speaking ability in French or Japanese a plus.Formal Education/Experience
Bachelors degree (ideally in computer programming or similar technical field) or equivalent work/life experience.
5 or more years experience performing clinical database design with one of the major commercial products (Clintrial, Oracle/Clinical, Recorder or Inform).
Minimum of 3 years experience developing complex edit checks, packages, and functions using PL/SQL programming.
At least 1 year experience supporting standards management, ideally including CDM database standards and programming standards.
Experience delivering training or mentoring others in the areas of standards, database design and PL/SQL programming (functions, packages).