Observational Post-Approval Study Manager

Supporting the Pharmacoepidemiology Group within Specialty Care at Sanofi. Working closely with Sanofi lead pharmacoepidemiologists, the study manager is responsible for supporting the operational delivery of three observational post-authorization safety studies ensuring regulatory-grade quality and compliance. Minimum of 3-4 years of progressive clinical trial and/or observational study experience is required.

Key Responsibilities

• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.

• Lead the preparation of any agreements related to the study, confidentiality agreements, any applications or other applicable country documents.

• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and clinical centers to facilitate the delivery of study data.

• Provide oversight of data delivery.

• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study results and meeting Regulatory milestones to the necessary quality, timelines or budget.

Required Experience, Skills, and Qualifications

• Bachelor’s degree or master’s degree, preferably in medical or biological science, or discipline associated with clinical or observational research, or equivalent experience

• Minimum of 3-4 years of progressive clinical trial and/or observational study experience

• Experience of working with and delivering through strategic partners and 3rd party vendors

• Be fluent in written and spoken English

Demonstrated the following behaviors:

• Team oriented

• Ability to coordinate and prioritize multiple tasks and deliverables

• Proactive approach

• High degree of flexibility

• Demonstrated verbal and written communication skills

• Good negotiation and collaboration skills

• Demonstrated interpersonal and problem-solving skills