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Job Title: Clinical Data Lead

Location: Woolloongabba, AUS

Position type: Full time, Permanent

Our Team/ Overview

• The Clinical Data Management (CDM) Vaccines team sits within Sanofi's Vaccines Global Business Unit (GBU). The CDM team is embedded within the broader Vaccines R&D /Global Clinical Development organization.

 The team's mission is to:

• Ensure the integrity, quality, and completeness of clinical trial data generated across vaccine studies (Phase I to IV).
• Enable scientific and regulatory decision-making by delivering clean, reliable, and analysis-ready datasets.
• Support vaccine approval pathways by managing data that underpins regulatory submissions to health authorities worldwide.

Main Accountabilities

• Ensures the oversight of external vendors/partners and contributes to all Data Management operational aspects needed for successful completion of a trial from Preparation up to Submission.

He/she is accountable for:

• Representing CDM with Clinical Team and other departments (Digital, PV, Labs) or external parties.
• In charge of databases Design, Deployment, Revision, Cleaning and Closure for assigned clinical trials using all specific CDM applications in line with Standards and Regulations (e.g. trial documentation, database testing and deployment, accuracy and consistency of data capture, data cleaning, identifying validation needs as coding, reconciliations, external data management and database lock).
• Provides locked clinical databases with adequate level of quality to allow for statistical analysis within requested timelines.
• Organizes and follows up on any technical activities’ requests for submission (Case report forms, specific tables, recoding, audit and inspection,) as appropriate.
• During the trial(s), be the voice of CDM in the Clinical Team, overseeing the development and implementation of CDM strategies to meet expected project/trial related goals.
• Ensures good understanding and application of the global CDM strategy by the Clinical Team.
• Proactively identifies difficulties in reaching project/trial timelines.
• In case of difficulties encountered, offers best practices and solutions to resolve it.
• Provides guidance and support to Clinical Teams with a focus on technical environment requirements, Regulatory guidelines and Quality documentation.
• Proposes and reviews potential process improvements for the platform.
• Coordinates or participates in initiatives/projects in CDM platform or Clinical department.
• Collaborates to any definition, update or review of Quality documents and guidelines related to activities.
• Mentors and coaches newcomers as Clinical Data Leads on all operational aspects needed for successful completion of a trial.
• When applicable, perform one or more following transversal activities as Clinical Project Lead, Subject Matter Expert or Champion:

 As Clinical Project Lead

• Ensures the oversight of a project, being the CDM point of contact within the project/clinical team, to meet timelines and submission objectives.
• Centralizes and communicates all decisions applicable to the project at CDM level.
• Coordinates CDLs activity within the project to ensure consistency across trials.

As Subject Matter Expert (SME)

• Is the expert of a specific topic and the point of contact for any user, including Pharma level
• Ensure the good understanding of the topic by the users and its maintenance and optimization.
• Force of proposal to evolve the topic
• Responsible for the assessment of any proposals related to the specific topic
• Interacts closely with Champions to provide focused expertise
• Contributes in any related activity led by champion

As Champion,

• Coordinates transversal activities/projects in their entire scope, within the platform, related to Tools, Processes, Standards or Risk management / Change management.
• Represents CDM platform at Sanofi level and within all teams involved in the domain (e.g. Governance, Core Team, Working group, Vendors/Third parties)
• Manages and promotes updated or new operational strategy in his/her domain.
• Ensures the appropriate level of communication and the good understanding at CDM platform level.
• Provides guidance and support to users within his/her domain of expertise, including training, coaching and mentoring to CDM staff in his/her domain of expertise.

Experience

• Skills and Experience in data management in clinical/medical field
• Knowledge of data management software and computing skills
• Project management skills
• More than 2-year experience

Certifications:

• Degree or diploma in Health/Life Science, Technical Sciences or other related area

Additional Accountabilities

• Is accountable to deliver accurate and reliable clinical data for global vaccine studies.
• This role requires a strong contribution to Clinical Teams as CDM voice sustaining CDM strategy.
• Communication with other platforms, departments (Clinical Programs, Clinical Sciences, GCI, CSO, Medical Affairs...) or Global teams (Digital, Pharmacovigilance, Regulatory Affairs…) or global external people as CROs/Partners, vendors/third parties.
• Raising decisions and alerts to managers that may have an impact on CDM strategy

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