IT Business Analyst Clinical

Contenu de l'offre IT Business Analyst Clinical chez Ipsen

IT Business Analyst Clinical

Title:

IT Business Analyst Clinical

Company:

Ipsen Pharma (SAS)

Job Description:

The role of IT Clinical Development Domain (CDO) and will be empowered to

Leads the analysis of business problems and the translation of business requirements into successful technical solutions and processes to meet business needs.
Analyze business partner’s operations to determine opportunities to optimize, automate processes and functions
Leads development of scope definition and business priority and will be responsible for proactively identifying technology solutions to meet business objectives, understanding complex business processes, eliciting, and documenting requirements, and coordinating communication, considering the implications of change on the organization and all stakeholders.
Lead integration projects of systems, data and contracts in the context of M&A
Focuses continuously on opportunities to improve or innovate business processes through technology, especially monitoring digital trends and fostering data integration solutions between applications in the business domain both internally and externally to the organization.

The main responsibilities are:

Customer-Centricity

Focuses on the customer’s experience with systems and tools
Views new requests, issues, improvements from our customer’s perspective.
Owns & tackles customer pain points and/or irritants and seeks opportunities to increase client satisfaction and adoption.
Proactively proposes innovative solutions to the business to address its changing goals and needs.

Guarantees the proper selection of IT solutions for the customer business domain

Understands the goals, challenges, plans, and processes related to the customer business domain.
Manages requirements gathering, prioritizing, and negotiating with business stakeholders to ensure the delivered solution meets or exceeds end user’s expectations.
Validates and interprets business needs by conducting feasibility studies and drafting business cases.
Develops the necessary documentation for solution selection, including as-is and to-be business processes and clear and testable business requirements, business use cases and RFPs.
Recommends business process and system changes to innovate and improve efficiency and business outcomes.
Assists in solution identification and selection, including recommendations for buy vs. build or on-premises vs. external implementations.
Solves or leads others to resolve problems, aiming to influence the business in a positive way. Evaluates ways of prioritizing opportunities to streamline business and/or system processes.

Participates as a key member of business solutions implementations

Assures proper selection, planning, implementation, testing and validation, training, and transition to Support of solutions which meet end user requirements.
Develops the necessary documentation for implementation and ongoing support of IT solutions projects, including test plans & scripts, and system application support, and end-user knowledge transfer.
Serves as a technical/functional expert for pilots, prototypes, application configuration and migration of historical data.
Helps facilitate clear communication and coordination between business stakeholders, IT delivery teams, and vendors.
Reports to management & steering committees, makes recommendations, suggesting options and acknowledging risks and mitigations.
May perform other project management activities as required.
Coordinates and communicates system lifecycle activities and ensures the solutions continue to meet the needs of the GMA business unit.
Ensures all documentation respects Quality standards, policies, and procedures.
Ensures delivered solutions are compliant with relevant legal and regulatory requirements.

Maintains current knowledge of IT and business domains

Acts as subject matter expert in the business area of expertise and actively share emerging industry standards/trends with customers and peers.
Understands and influences vendor solutions/roadmaps and industry technology advancements along with evolving regulatory requirements.
Monitors technology and methodology evolutions in his/her domain.
Maintains knowledge of the business domain, and the specific IPSEN organization and its objectives.

Maintains current applications within the domain

Identifies points for continuous improvement and contributes to their implementation

Recommends system changes to innovate and improve efficiency and business outcomes
Contribute to solve problems and challenge that occurs in existing solutions already in place
Participate to release management
Participate in Change Advisory Board
Follow up support management done by AMS vendor

Participate in integration projects the context of M&A

Scope the processes, systems, contract of the acquired company
Define an integration plan with timeline, costs, resources
Activate the integration plan to the full integration and decommission
Develop the necessary documentation associated to integration project

Experience / Qualifications

Experience & Qualifications:

Ideal: Master’s Degree or Engineer in the R&D business domain relevant to pharmaceutical or biotechnology clinical development operations, with at least 3 years of experience working as an IT professional in a similar position. Biotechnology or pharmaceutical industry experience is required, with double competency in IT and clinical development operations domains (or R&D) highly desirable.

Other Specifications:

Knowledge of processes and solutions related to Clinical development and more specifically Statistical platform (SAS), Data Standards (CDISC) and data management systems (including submission packages) in the context of clinical development (both clinical and non-clinical studies).
Knowledge of business processes and technology landscape for pharmaceutical or biotechnology industry in the clinical development operations.
Experience with international and/or multi-site IT projects is required.
Knowledge of computerized system quality and lifecycle processes, with specific experience in GxP validation processes is required. Knowledge of procedures and best practices related to FDA, EMA, GxP (GCP in particular), CFR 21 Part 11, Computer system validation.
Knowledge/experience of Pharmaceutical Environment (R&D in particular)
Knowledge on SAS Platform is a plus

Languages:

French fluent mandatory
English fluent mandatory – Daily working language

Main required knowledge

Experience in IT project management in a GxP Environment
Experience of R&D and in particular clinical development
Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.

Summary

Location: Boulogne

Type: Full time