Assistante Essais Cliniques

Title:

Assistante Essais Cliniques

Company:

Ipsen Innovation (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Main responsabilities

Coordinates and conducts the following in-house and external clinical operations activities:

• Sets-up and maintains shared study electronic site (SharePoint, box or other tools) using templates . Ensure all these folders are up-to-date with all the information.
• Organize appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...) including Investigator’s meeting, DRM & TFLs, Steering Committees etc
• Responsible for internal meeting agendas/minutes as applicable, recording, disseminating and documenting decisions and actions (ie. the study oversight tracker)
• Coordinate training for the assigned clinical study and track & maintain study team training logs
• Responsible for study laboratory sample tracking and vendor management support working closey with the CMLs
• Records Service Provider (SP) contract in Ipsen database,  ensures contract signature by Ipsen and SP and secure proper filing and archiving of all fully executed contracts
• Collect and ensure signature by Ipsen of all legal administrative documents such as Power of Attorney (POA), Letter of Authorization (LOA), Confidentiality Disclosure Agreement (CDA), Kbis…
• Ensure documents required to obtain insurance certificate and renewals are being requested by Ipsen and CRO prior to the study start-up and during the course of the study. Requests the insurance documentation as per country requirements. Ensures insurance premium budget is in the study budget and works with risk management to solve any issue or query to get documents in a timely manner
• Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs
• sr CTA :  Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors. And can input in study risk management and establish mitigation plans

Responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)

• Accountable for the set-up and administration of the Ipsen electronic TMF (and/or paper TMF, if applicable) for the clinical study
• Work closely with the TMF specialists to manage the clinical study eTMF creation and set-up for the country and site binders and the trial milestones
• Prepare and customizes the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners
• Track the arrival and departure of new study team members at CRO/Ipsen
• Ensure the TMF is up-to-date and all essential documents are appropriately filed in the TMF by the respective document owners
• Perform continuous oversight of the CRO/Ipsen TMF activities, uses metrics and reports for checking the documents