Hiring company: Sanofi
Position Overview:
The risk-based monitoring(RBM) is an adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.
Principal Central Monitor is accountable for the end-to-end risk-based management activities and brings insights for studies and the CMs response to the TA studies through summarized TA experience and industry trends to ensure data quality, patient safety, and trial reliability. The principal Central Monitor is also responsible for developing and implementing the TA RBM strategy. Make sure the consistency and enhancement at the TA level. Thus, acting as risk experts through the data aspect on the TA level.
Key Responsibilities:
At the TA level, develop and Implement the risk-based monitoring strategy for all studies including analysis scope, analysis schedule, and analysis method, etc. according to TA specificity and Sanofi standards.
Build and maintain TA knowledge pool based on latest regulation requirements, technologies, guidelines, etc., then share and update on an ongoing basis.
Customize TA level KRI pool and DQA set-up notes, also driven continuous optimation by focusing on TA specific data.
Support and oversight on TA-related CM’s deliverables of RBM activities, including but not limited to, KRI spec review, DQA set-up notes review, root cause analysis consultation, etc.
As TA level RBM expert to collaborate with internal/external working groups to optimize the process.
Proactively collaborate with related RBM DS to customize TA level RBM approach.
Assist to the resource allocation within TA.
Knowledge And Skills:
Deep knowledge and experience on specific TA.
Experience with risk-based methodologies and regulations.
Strong capability in root-cause analysis and strategy thinking.
Strong data management expertise, and clinical operational experience.
Well understand the site management activities.
Strong project management skills and experience to make sure delivery on time with high quality.
Must possess excellent communication skills to be able to effectively convey messages with internal and external members.
Ability to proactively identify potential risks in order to establish risk-based and preventative mitigations.
Well establish a risk-based mindset in all of the activities involved to focus on what really matters.
Familiar with the end to end clinical data flow and data structure.
Be sensitive to atypical patterns in data analysis.
Ability to analyze protocol designs, processes, vendor capabilities, data flows and data trends to design RBM strategies.
Solid knowledge in the clinical trial development process. Understanding of relevant and current regulatory guidelines, GCP, and industry standards and practices directly or indirectly impacting risk-based quality management.
Able to understand and operationalize new Drug Development models to support complex protocols and decentralization of clinical trials.
Knowledge of company tools, processes, and SOPs.
Learns and adapts quickly when facing new problems. Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.
Good interpersonal, communication, and negotiation skills.
Be good at presentation and meeting hosting.
Able to acquire and apply new technical skills.
Strong English skills (both verbal and written), ability to exchange fluently.
Basic Qualifications:
Bachelor degree or above, preferably in a life science or drug development related field.
A minimum of 8 years experience in the field of clinical research of which 5 years must have been in a project management role. (or equivalent).
Experience in risk-based monitoring activities is a plus.
Knowledge And Skills Desirable But Not Essential:
Experience in clinical research tools, such as Medidata Rave, CluePoints, IMPACT, etc.
Experience in data analysis powered by modeling and AI methodologies such as ML.
Knowledge of database technologies and processes.
Data programming language, such as SAS, R, Python, etc.
Knowledge of risk lifecycle management process.
In-depth therapeutic, protocol, country/site feasibility knowledge.
Understanding of industry standards and terminologies (e.g., CDISC SDTM, MedDRA, etc.).
Experience in conducting data/site management activities for Decentralized Clinical Trials and Complex protocols such as “Basket”, “Umbrella”, and “Adaptive”.
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.
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