Senior Central Monitor

Job description

Our position

·  Job title: Clinical Senior Central Monitoring Manager
·  Location: Budapest, Hungary
·  Flexible working: 60% home, 40 % office (remote is negotiable)
·  Job type: Permanent full-time

About the job

An exciting opportunity to join our risk based monitoring team. Risk-based monitoring (RBM) is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes which have the most potential to impact patient safety and data quality. In this context, the RBM team is responsible for designing, executing, and optimizing the Sanofi RBM approach to align with regulatory requirements and Sanofi's objective to drive quality, efficiency, and speed of clinical trials.

Senior Central monitor will use centralized 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 develops study RBM strategy and is involved in the study risk management cycle. You’ll brings 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. An exciting data driven role which has lots of scope for growth and development.

About Growing with us

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 statistical 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.

About you

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.
·  Trial ops or clinical monitoring experience including CRA, Clinical Study Data Managers, Project managers, Associate or Global Study Managers, QA, or clinical project related.
·  Willing to analyse 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: 

·  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.

When joining our team, you will experience:

·  An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
·  An attractive, market-oriented salary and cafeteria benefits.
·  Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
·  Work from an "Office of the Year 2020" finalist office.
·  Collective life and accident insurance.
·  Yearly medical check-up.
·  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.
·  Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
·  Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).

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, ability, gender identity or Veteran status.

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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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.