该职位来源于猎聘 Main responsibilities and tasks:

• Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget
• Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain…) and CROs
• Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD) and other relevant Ipsen team members
• Lead cross-functional clinical study teams focused on conduct of assigned projects
• Interact with CDPD to define strategic direction
• Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
• Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs Develop, manage, and execute assigned projects by:
• Set-up study team before Services Provider / CRO are on board and lead and manage regular internal Study Team meetings during the course of the study.
• Contribute to study protocol development including study concept where applicable
• Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO
• Provide expertise and ensure appropriate subject matter expert is involved in setting clinical outsourcing specifications to purchasing, to facilitate RFP documents and selection of Services Provider/CRO
• Participate in the selection of Services Providers /CROs and other external vendors in collaboration with subject matter experts and purchasing department, study team and Corporate Legal Affairs
• Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
• Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document
• Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, monitoring plan, risk management plan project plan, instruction manuals….)
• Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites
• Provide support and oversee the activities of the Clinical Trial Assistant (CTA) assigned to the study for: insurance certificate, contracts signature process, set-up and managementof the Trial Master File (eTMF), transparency and local reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes,…) and alert if required; drive billing and forecast
• As applicable, provide support and oversee the activities of the Clinical Lead (CL) to ensure the coordination of the clinical vendors, monitoring and site management activities are in accordance with study objectives and quality standards.
• Work with the CRO, Patient Affairs office, and digital team as appropriate to develop and approve a recruitment strategy and communication tools (e.g. Newsletter…) to increase study awareness, patient recruitment and retention in the study
  
  

Experiences

Relevant experience of pharmaceutical drug development:

• Experience of minimum 1 year (ideally 2 years) of PM.
• Coordination of clinical activities for the setup, conduct and reporting of international registrational studies, for at least 8 years
• Experience in managing and developing relationships with Contract Research Organizations (CROs)
• Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment. Qualifications :
• Life science or medical graduate or other relevant qualifications. Languages : very good English language knowledge (oral and written)