CSU Systems Expert

Job description

JOB PURPOSE:

·  This role is responsible to develop and maintain a local/region expertise of supporting solutions and services supplied centrally to the local teams in the Cluster/country in order to run the clinical trials performed by the Clinical Sciences Operation Platform (CSO).
·  This includes but is not limited to:
·  Clinical Trial Management Systems (CTMS) support
·  Electronic Data Capture support (both internally and externally)
·  Clinical Trial Portal support
·  Collaborative Tool support
·  Account Management
·  Access Management
·  Reporting tools
·  e-communication tools (internet/intranet page, Zoom, videoconferencing, etc)
·  The System Expert is the main contact person for the local teams in the Cluster for all service aspects and liaises closely with the corporate support teams and with the local affiliate ITS departments. If needed, the SE will also be in contact with the study sites.
·  The SE is accountable for tracking the timely performance and compliance with the systems. Identifies and implements efficient processes to handle the support systems and services within the local team. Responsible to identify issues and to communicate specific requests to the corporate support teams. Supports the improvement of processes/tools on a global level.
·  Actively collaborates and interacts with the Cluster Head and local CSU management. The SE participates in team meetings as deemed necessary. Exchanges experiences and solutions with system experts within the region and SE network.
·  Is responsible to set up and perform necessary trainings for all support systems and to implement tracking of all training sessions (inside and outside) attended by the local teams or ensures the use of a central tracking within the corporate environment. Supports the data quality by providing the local team with coaching on best practice and guidelines, (technical) information (e. g. compliance reports) and problem solutions to the local teams.
·  Drives digital innovation within the CSU.

KEY ACCOUNTABILITIES:

·  Support local team in the setup of Rave/Electronic Data Capture studies and sites (including management of user accounts) and ensure successful operation of eCRF system.
·  Train all system users within local teams across English Speaking Africa Countries. Provide first line business support for CTMS to local users in cooperation with corporate team.
·  Support the local management and teams in the use of standard reports in iReports and CTMS, and ensure adherence to data entry requirements, data quality and adherence to data privacy process by regular review of reports/systems.
·  Responsible for maintenance of further central tools used for communication (e.g. websites for patients and investigators, communication tools).
·  Assist in the development and communication of the local data privacy processes and ensure adherence to this process.
·  Estimate hardware need for Cluster and liaise with the local ITS department and hardware suppliers.
·  Create, review, update and train on SOPs and Working instructions when needed.
·  Support local team, including clinical research sites, in the use of the Clinical Trial Portal/electronic Document Management Systems along with the technical activity of library management at local level.
·  Give support, including for clinical research sites, on questions related to systems, portals and tools and escalate when appropriate.
·  Run reports for main performance indicators, analyze and propose improvements and escalate when appropriate.
·  Assist in the development and implementation of electronic CRF for local/regional studies when required.
·  Develop relationship with System Experts within the region in order to exchange experiences and solutions.
·  Compile, analyze and propose corrective and preventive action plans for most frequent questions and problems related to systems, portals and tools and escalate when appropriate.
·  Ensure information are qualitatively and quantitatively updated in systems, portals and tools related to clinical research activities and ensure data restorability.
·  Coordinate the creation and deactivation of accounts, internal and external accesses, ensuring adherence to Privacy Policy.
·  Coordinate adequate usage and availability of portals and communication tools (e.g Internet/Intranet, etc).
·  Align with local ITS equipment needs and applicable programs for the conduct of clinical research;
·  Ensure review, update and implementation of related quality documents.
·  Ensure implementation of global/regional improvement projects.
·  Ensure preparation and proper response to audit/inspection reports concerning Tools and Systems and implementation of recommendations.
·  Ensure local inspection readiness at all times with appropriate oversight of Tools and Systems.
·  Share lessons learned and ensures adequate deployment of possible identified action plans for improvement within the cluster and, if applicable, across the region.

Core Competencies:

·  Ensuring a consistent approach to training across a large and diverse group in-house and remotely based.
·  Providing leadership as a subject matter expert within the CSU.
·  As the expert, this person will provide leadership for all training requirements relating to corporate Tools & Systems to be implemented and in use for clinical studies.
·  Computer skills must include working knowledge of MS Office suite
·  In- depth knowledge of GCP/ICH phase 1-IV Clinical trials
·  Good communication skills
·  Results Driven
·  Problem solving skills

Behaviour:

·  Setting ambitious objectives while knowing how to take risks
·  Developing skills, training and enabling learning on the job
·  Developing innovative solutions and ways of doing things
·  Making decisions & driving necessary changes for performance
·  Knowing how to deal with conflict
·  Guaranteeing performance in the short, medium and long term, while respecting our values
·  Commit to customers
·  Act for change
·  Cooperate transversally
·  Strive for results

Knowledge and Skills (minimum requirements):

·  Good knowledge of spoken and written English
·  Background or good knowledge of IT systems
·  Experience and expertise in clinical research (preferably as CPL)
·  Customers & quality focused
·  Effective management skills: Management of communication and Information; Networking; Team working; Sense of Urgency; Results oriented; Commitment; Proactivity, ability to teach others.

JOB-HOLDER ENTRY REQUIREMENTS :

Education:

Bachelor of Science degree or equivalent

Experience :

Minimum of 5-10 years of experience in the pharmaceutical industry with minimum of 5 years of experience in Clinical Research. Knowledge of MS Office, Internet, CTMS, EDC. Desirable at least 1 year of coordination responsibility.

S anofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below

https://sanofi.wd3.myworkdayjobs.com/SanofiCareers

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