About us

At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients.

Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.

~ 43.07Bn€ Net Sales FY23

~90 countries

~ 91K employees

~ 59 manufacturing sites

~ 20 R&D sites

About the role:

Senior Central monitor will use centrailized monitoring platform (CluePoints) to monitoring clinical trial data that involves the collation of data from study site in a central way. You will provide support to studies across different TAs, countries and teams and review the structured clinical data output.

The Senior Central Monitor is one of two roles under RBM team who is responsible for managing the execution of the RBM activities for assigned study(ies) from protocol design to database lock. You’ll develop study RBM strategy and is involved in the study risk management cycle. You’ll bring insights through analyzing the clinical and operational data to ensure data quality, patient safety, and trial results reliability. You will also drive and cooperate with local team to implement adaptive monitoring strategy and facilitates the efficient and effective performance of the site monitoring activities.

Main responsibilities include:

• Providing input to critical data and process identification, study risk assessment, and preventative mitigation plans.

• Perform centralized monitoring activities on assigned studies where you’ll detect the risks based on statisicial methodology and identify data quality, site operational risks of the study as per the protocol, SOPs respective regulation and guidelines.

• Implementing and owning the study risk-based monitoring strategy and Quality Tolerance Limits (QTLs) operationalization including analysis scope, schedule, and methods, based on study timelines and Sanofi standards.

• Monitoring Key Risk Indicators (KRI) and performing Data Quality Assessments (DQAs) to identify high risk sites and countries to drive activities and timing of on-site/remote monitoring in collaboration with study and monitoring teams.

• Performing timely and proactive root cause analysis leveraging both clinical data and operational data to make independent decisions on identifying data related signals, and providing robust corrective actions as well as preventative recommendations.

• Contributing to process and methodology optimization stemming from the industry evolution.

• Facilitating early identification of risk/issue(s) occurring during study conduct and responsible for identification of risk alerts, timely escalation of risk/issue(s) to relevant stakeholders (e.g., study manager, on-site monitors/CRAs) and tracking of risk/issue(s) until resolution.

• Acting as a single point of contact for relevant stakeholders (on-site monitors, study managers, safety/medical monitors, data managers, etc.) for allocated risked based centralized monitoring studies and ensure timely communications.

Experience:

• Experience of trial operation or data management or quality management

• Knowledge of clinical research regulatory requirements; i.e. ICH GCP and relevant laws, regulations and guidelines, towards clinical trial conduct

·Willing to analysis data and provide insights

Soft Skills:

·Strong project management skills.

·Be able to learn and adapt quickly.

·Good interpersonal, communication, and presentation skills.

Technical skills: 

·Trial ops experience including CRA, Clinical Study Data Managers, Project managers, Associate or Global Study Managers, QA, or clinical project related

·MS Office- Excel, Word, PowerPoint & SharePoint

·Able to review or learn to use the business intelligence dashboard.

Education:  BSc. in Life Sciences(or equivalent), Masters is a plus

Languages: Strong Command of English  (Verbal and written), ability to exchange fluently in a global environment

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, 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!