Work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities.
Provide internal consultancy and thought leadership with regards to the conduct of clinical research
Design study synopses and develop research protocols aligned with integrated evidence generation plans (IEGP) that will support the study through Ipsen approval pathways.
Preparation of the study Set-up and lead the study Cross Functional Team (CFT) overseeing study design and kick-off activities.
Initiate high level feasibility and continuously monitor how changes to the study design affect feasibility during the preparation and development of the study protocol.
Own preparation of the project budget including financial and clinical supply forecasting.
Develop the study timelines planning for critical events and milestones as agreed by the Cross Functional Team.
Lead the SP selection process.
Requirements
Strong project clinical operations experience
Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs
Significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs
Experience and know-how in Oncology or in Rare Diseases or in Neurosciences
Proven track record of delivery of projects to time, budget and quality.
Extensive track-record of interactions with country Medical Affairs Staff
Experience of managing and developing relationships with Service Providers
Fluency in English.
Benefits
Employee Care: We care for our employees, who are the ambassadors making a real difference.
Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.