Clinical Trial

**Title**:
Clinical Trial & Application Registry Project Manager

**Company**:
Ipsen Innovation (SAS)

To ensure Ipsen compliance with legal, regulatory and industry guidance on clinical trial transparency, your missions will be:
**Ipsen strategy on clinical trial transparency**
- Develop and update the Ipsen strategy on clinical trial transparency, clinical trial information disclosure on registries and Ipsen corporate Website, in close collaboration with Patient Centricity department
- Ensure readiness and alignment of the Ipsen strategy with future regulation

**Maintain awareness of relevant legal, regulatory and industry requirements**
- Track requirements on trial registration and data release requirements from agencies including but not limited to FDA, EMA, European Union;
- Track development of industry guidance from EFPIA, PhRMA and national groups;
- Benchmark activities of other pharmaceutical companies and emergence of standards in this area;
- Keep senior management informed of actual and anticipated developments in requirements for Ipsen

**Develop processes to ensure Ipsen compliance**
- Identify public databases where Ipsen needs to register its trial and post results;
- Develop and maintain efficient processes according with the strategy developed to ensure compliance with current and future regulations on time in cost-effective manner
- Communicate with Ipsen stakeholders in these processes (Clinical Operations&Biometry, GPS, GMA ) to ensure that they understand their roles and ensure alignment and consistency with impacted processes

**Ensure appropriate resourcing. Anticipate and review budget**
- Develop and maintain plans of trials needing registration and results posting;
- Develop plans for out-sourcing of relevant activities in line with Ipsen strategy;
- Plan internal and out-sourced resources to ensure timely compliance;
- Ientify databases contributing information to registration processes and develop and/or acquire software to make processes more effective.
- Anticipate annual budget and review them quarterly.

**Supervise and contribute to trial registration and results posting**
- Manage the Clinical Trials Registry team activities to ensure registration and results posting for relevant trials on databases
- Ensure compliance with national requirements for trial registration and develop processes to support local teams and ensure consistency of information posted in different registries;
- Enter trial registration information and results as needed

**Plan and coordinate Ipsen’s activities in relation to Data Transparency**
- Being driving factor in Clinical Data transparency projects
- Ensure Ipsen’s Data Transparency policy is published on the Ipsen website as part of the Publications policy or as a separate document;
- Establish and manage the Clinical Trials Data Transparency Board to assess requests for trial data from independent researchers
- Ensure that contributing departments understand their role in releasing data under emerging Data Transparency requirements from EMA, European Commission and EFPIA/PhRMA principles.

**Transversal Project Management**
- Management of/Leadership on projects, not only directly linked to Clinical Data Transparency to ensure Ipsen compliance of GRQ department to legal or Regulatory requirement.
- Working as key contact and project lead for GRQ activities that require collaboration with other stakeholders.

**EHS Responsibilities**
- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system
- Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
- Ensure the completion of mandatory EHS training by his collaborators

**Experience & Qualifications**
- ** Ideal**
- Previous experience of pharmaceutical company data transparency operations
- Experience of liaising with regulatory authorities
- Experience of liaising with external scientific and medical researchers
- Previous experience of setting up or maintaining clinical trial registries
- Fluency in French&English languages
- ** Minimum**
- Graduate qualification or equivalent experience in a discipline relevant to Clinical Trials
- Excellent understanding of clinical trials designs and management
- Clear and accurate verbal and written English communication skills