The Clinical Database Analyst is the expert and responsible for developing and implementing database elements (structure, data entry screens, edit checks) and he/she is also responsible for setup of peripheral tools of clinical database collection system. He/she ensures that any study databases are set up according to defined timelines. He/she manages the study databases in compliance with the worldwide clinical standards to support a flawless conduct of clinical trials. He/She is the expert for clinical study database metadata structure, programming and maintenance activities.
KNOWLEDGE AND SKILL REQUIREMENTS
(Minimum requirements for assignment to this job.)
A. Knowledge And Skills:
• Expertise in Clinical Data Management Systems (e.g. Medidata Rave) and in the use of Data Management applications and database/file structures
• Expertise in database administration, design/programming, query language and metadata validation
• Knowledge of industry standards and practices (e.g. CDISC/CDASH)
• Custom function programming ability by using C#
Problem solving & Decision making
• Anticipate complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.
• Ability to analyze issues (i.e. context, impact risk)
• Ability to make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
Oversight & Coordination
• Ability for performing quality controls and ensuring maintenance on databases
• Strong organizational skills and ability to handle multiple tasks, paying attention to details and defining priorities.
Act for change
• Be flexible to change, managing internal and external challenges & opportunities
• Readily adapt to new environment, jobs, technologies and processes (e.g. new CDMS, tools, process of UNIFY)
Collaboration and communciation
• Excellent interpersonal and communication skills, with other departments and external partners.
• Sufficient competence in English to ensure CDA activities
B. Knowledge And Skills Desirable But Not Essential:
• Experience with SAS and/or other programming/query languages
• Experience supporting standards management, ideally including CDM database and programming standards
• Oracle DBA knowledge
• Clinical data management experience
• Clinical trial knowledge including phase I to IV
• Experience working in a global team/environment
Briefly describe the major duties and responsibilities for which the job is held accountable (please rank in order of importance.)
RANK MAJOR DUTIES & RESPONSIBILITIES
(what the job does) END RESULTS EXPECTED
(why is it done/impact)
1. - Responsible for implementing standards and studies in current clinical data management systems.
- Responsible to commit realistic time schedules for database set up delivery
- Responsible for clinical database administration (creation, modification, distribution, lock). - All standards and studies are implemented acccording to Sanofi SOPs, processes and standards to ensure high quality of data management
2. Expert contact for Data Managers (DMs) or CTOM (Clinical Trial Operation Manager) concerning database support activities; proposes solutions for data management issues that arise during study conduct. All databases are compliant with the level of quality required by ICH/GCP in order to deliver reliable and accurate data computerized for statistical analysis
3. Request new database models or updates to the CIG (Clinical Information Governance) team for validation Continous improvement of database standards implementation
4. - Expert contact for new technical solutions (associated with clinical data management systems) implementation and processes in interaction with the appropriate working groups.
- User testing of relevant software patches/upgrades - New solutions are implemented
- New softwares are implemented
5. Within database design, standards group, continually evaluates processes and applications for improvements, as well contributes to improvements within CDM generally.
Participates in the implementation of department initiatives (e.g. new tools, new standards, process 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 Standard Implementation Head, Study Implementation Manager, when appropriate. Best practices applied to all aspects of database design activities.
COMPLEXITY & PROBLEM SOLVING
A. Major Challenges/Problems. List challenges or problems commonly encountered in this job, how they are solved, and with whom they would typically be solved.
High quality databases designed to capture all necessary data in support of a protocol's aims (with SDMs/CTOM and standard group, as well statistical programming or other CTT members, if applicable).
In cooperation with his/her manager aggressive timelines managed effectively.
B. Decision Making Authority. Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.)
Responsible to create and maintain standard/study databases and to assure all CDM standards are kept and respected. If any new features (e.g. items, panels, edit checks, functions, packages) are requested, which are not yet approved, the Database Design Manager and/or Standard/Study Manager has to be informed for further actions.
Responsible for identifying and solving issues/problems, which prohibit a normal data processing. Whenever new or complex issues are faced, the Database Design Manager and/or Standard/Study Manager has to be informed for further actions
Responsible to initiate proposal for new standard developments or updates when appropriate
C. Key Internal and External Relationships. Describe the most significant contacts outside the regular work unit. Include frequency and purpose.
Global Head of database design and standards group, Standard Implementation Head, Project Leader, Study Data Managers, Clinical Data Coordinators, CTOM, Data acquisition team, DM programmer, Local trial operation head
Programming standards expert (PSE), Statistical programming, CROs
JOB-HOLDER ENTRY REQUIREMENTS:
Bachelor degree, preferably in a life science (e.g., clinical medicine or pharmacy) or mathematics-related area (e.g., computer science or similar technical field).
At least 1 year experience in clinical database design and maintenance are required. In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred.