Clinical Operational Data Steward Leader

• Job title: Operational Data Steward Leader
• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working
  

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our global Data Intelligence for Clinical Operations (DICO) team as an Operational Data Steward Leader and you’ll be accountable for the strategy and coordination of the E2E governance of clinical operational data: study design characteristics, study stakeholders (study team members, vendors, investigational sites, HCPs…), study milestones and status, study recruitment data. You’ll also present this strategy to Top Management via the DICO Steering Committee.

Main responsibilities:

1. Liaise with study teams - Study support for operational data

•          Serve as Strategic primary contact for end-users within Clinical Operations answering to any questions, requests from other functions. Coordinate the requests review management of study-specific operational data at study level and / or updates in dictionaries in master data systems, based on customer needs. Understand business needs of study end-users, define or update operational data and associated process and quality rules.

•          Coordination of transversal groups to manage Use Cases to align operational players for agile/fast decision making and delivery of common operational deliverables. Ensure cross-functional vetting and awareness of implementation activities across Therapeutic Areas. 

•          Lead the implementation of the effective solution in addressing quality and consistency measures depending on data criticality, including definition harmonization, investigations and impact analysis for functions using these data. 

2. Clinical Operations Data Foundations

•          Lead the management of Operational Data Standardization (definition, dictionaries, data flow to consuming systems…) in using common vocabulary for a same concept used by several functions. Supervise the reference data development and cleaning in a harmonized way in systems.

•          Drive policy-related actions: Streamline processes and associated quality documents (global SOPs, policies, guidelines…) that describe the management of the operational data and implement new working practices. Define the level of control based on data criticality (ex: Reg transparency… vs internal). 

•          Recommend data flow optimization, capitalizing on electronic tools, to address new requests and assess their impacts to shorten the cycle time and improve overall quality. Manage regular analysis of information reported from a broad variety of sources. Lead the digital transformation to implement an automatic process (AI, ML, NLP…) linked to the operational data to propose data related evolutions.

•          Define and coordinate the monitoring of data governance processes adherence to target model and good use of data in clinical trials managed by Clinical operations (KPI or data quality metrics and deviations from acceptable levels). 

3. Train and communicate

Support the DICO Head in change management activities to drive a data-driven R&D organization:

•          Drive supporting documents for communication, education and trainings related to Operational Data assets

•          Organize communications on updates or evolutions, users feedback, exchange of best practices and lessons learned. Promote operational data activities (including new usages)

About you

Experience:

• At least 5 years in Clinical Development with background in clinical study management. Background or great interest in databases management.

Soft Skills:

•          Good communication skills and ability to facilitate common understanding of people with various backgrounds, collaborative spirit

•          Strong organizational skills, efficiency in matrix organization. Ability to effectively handle multiple tasks and to prioritize, results oriented

•          High level of autonomy and commitment

•          Customers & quality focused. Ability to simplify complex processes in developing guidelines and tools  

•          Flexible and Open-minded, Eager to learn with interest and ability to understand new perimeters

•          Problem-solving and decision-making capabilities, with analytical and synthetic spirit.

•          Project management skills: able to monitor a process, and lead to progress and results. Ability to anticipate, timely escalate issues and define appropriate action plans.

•          Good Knowledge and familiarity with industry standards and practices, clinical development process, international regulatory guidelines and GCP requirements

•          Good English Communication level (written and oral) 

Technical skills: 

•          Excellent transversal understanding of the Data Flow and Data Management processes in Clinical Development. 

•          Experienced with clinical data management systems and has a sound understanding of database and programming concepts, database structures, file structures (CTMS and satellites, planning tools…)

•          Interest for technical evolutions – Digital-oriented. Up to date knowledge on clinical governance systems such as MDM, Data Catalog and data mapping solutions

Education: 

PharmD or Master’s degree in relevant scientific and/or medical field 

Language(s):

• Strong English skills (verbal and written), ability to exchange fluently in a global environment

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

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