At Sanofi our Clinical Data Management mission is to operationalize the trials of tomorrow to flawlessly enable complex study designs in a decentralized and patient centric framework. As such, Clinical Data Management is evolving from a “one size fit all and EDC centric function” to an organization applying “fit for purpose and risk-based CDM methodologies within a highly decentralized clinical trials framework”.  This required evolution represent a unique opportunity to rebrand yourself as an industry leading expert. Join us and move your Clinical Data Management career to the next level!

The Clinical Data Manager (CDM) is supporting and in some cases leading the data management activities and associated quality deliverables for clinical trials including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance.

This includes assuming the Study Data Manager (SDM) role independently

• Completing DM related data validations and reviews during the conduct and close-out of a study.
• Contributing to the protocol review, Study Risk Management Plan, deviation review, medical review, data surveillance and other review activities during the conduct of a study.
• Supporting the User Acceptance Testing (UAT) of DM tools for both initial GO-Live and Change Controls.
• Drafting core DM study deliverables such the Data Management Plan.
• Preparing pre-lock summaries and study updates.

This includes assuming the Lead Study Data Manager (L-SDM) role with moderate Supersivion:

• Being accountable for the quality of data management deliverables and for the delivery of accurate and reliable clinical study data to ensure the reliability of the study results.
• Representing Clinical Data Management in the Core Trial Team (CTT). Liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all data management activities for assigned studies, discuss timelines, and provide study data management updates. Suggesting solutions for data management issues that arise during the conduct ofa study and monitor until resolution.
• Planning of all data management activities considering the core study milestones and ensuring that DM activities are conducted as planned.
• Leading DM activities with internal DM delivery team (Database Developers, Data Management Programmers, Central Monitors, etc.) assigned on the study and mentoring new SDMs.
• Accountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations as per company standards and protocol requirements.
• Assuring that data management standards are followed.
• Managing study document archiving in eTMF according to eTMF guidance.
• Supporting Investigator Meetings and other outside meetings if required.

When necessary, acting as a Study Data Manager contributing to the delivery of data management activities.

• Maintaining knowledge of current regulations and technologies related to the data management function.
• Defining and implementing the study data cleaning and validation strategy integrating risk-based approaches.
• Coordinating, in collaboration with vendor(s) and internal data integration experts, all external data activities: loading, integration activities and reconciliation activities, including Central Labs, eCOA, IRT, etc.

Knowledge and skills

• Intermediate data management expertise (i.e., understanding of data management scope and objectives).
• Strong English skills (both verbal and written).
• Solid project management skills and experience. Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact.
• Able to learn and adapt quickly when facing new problems. Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.
• Strong collaboration behaviors; manage effectively activities with study team and other DM functions. Establish rapport and collaborates inside and outside the company. Demonstrate flexibility through effective negotiations.
• Solid knowledge of the clinical trial development process and understanding of relevant and current regulatory guidelines, GCP and industry standards and practices regarding data management.
• Basic Clinical Data Management System experience (CDMS) and understanding of database/programming concepts. Expertise in the usage of Data Management applications and database/file structures.
• Follow through with all tasks and ensures high quality results. Set clear assignments as well as clear objectives and measures. Monitor process, progress, and results. Consistently meets deadlines according to accepted levels of quality. Pays attention to details.
• Ability to work as L-SDM role with moderate supervision while being able to support transversal activities.
• Good interpersonal and communication skills.
• Proficiency in Microsoft Office Suite (intermediate level)

Education and previous experience

Bachelor’s degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) and 1+ years of experience in clinical data management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in data management is desired.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.