Senior Study Data Manager
Cambridge, Massachusetts, Bridgewater, New Jersey
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The Senior Clinical Data Manager (Sr CDM) is responsible for leading the end-to-end 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. Ensure activities are completed according to agreed standards and timelines. Serve as the DM representative in the study team. Provide comprehensive data management expertise and support to team members. Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial.
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 Joint Clincal Operations Team (JCOT). 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 of a 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.
Participating in 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.
Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of a study.
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.
Participating in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.
Ensuring vendor oversight on data management activities while maintaining a good working relationship with the vendor(s). Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.
Knowledge and Skills:
Strong data management expertise (i.e., understanding of data management scope and objectives).
Strong English skills (both verbal and written).
Strong project management skills and experience. Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact.
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.
Solid 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.
Autonomously works as L-SDM role with minimal supervision while being able to support transversal activities.
Vendor management experience and good partner facing skills are preferred.
Good interpersonal and communication skills.
Proficiency in Microsoft Office Suite (intermediate level)
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences).
5+ years of experience in clinical data management in the pharmaceutical industry (or equivalent) is required. Experience Oncology Therapeutic area highly desirable.
2+ years of project management experience in data management is required.
* At Sanofi we have a hybrid model which allows you to work from home 2-3 days per week.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.
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