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 consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant Ipsen study team members
• Coordinate the TMF Quality Check (per Ipsen SOP) with the CRO/Ipsen to ensure the eTMF inspection readiness.
• Coordinate the final TMF reconciliation with the CRM/CPM
• Accountable for the archiving of the TMF

Responsible for follow- up and review of financial documents, in collaboration with CRM/CPM

• Create and update financial information within the Ipsen financial K2 system (commitment request, Internal Order, Purchase Order, goods receipt & invoices),
• Create and update the specific clinical study budget trackers, reviews for accuracy with CPM and controlling on a regular basis
• Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM. Ensures that all the vendor invoices are paid in-time. Works closely with the CPM, CRO and financial controller to resolve any issues
• Support the CPM in the clinical study budget management such as forecast preparation and managing/tracking the budget

Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force:  EFPIA disclosure code (Europe), Sunshine Act (US)

• Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect)
• Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
• Check the data received from the CROs with the support of the CRM/CPM
• Ensure the information is properly recorded in the COLLECT system, implement corrective actions where needed
• Ensure the Transfers of value collected (directly or via the CROs) in COLLECT are validated along the way in compliance with the disclosure timings requirements. 
• When needed, create new HCP/HCO records in the COLLECT system
• Where applicable, check the disclosure consent of Healthcare Professionals (HCPs) for each activity
• When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system

Responsible for data entry and status updates within the Ipsen study visualization platform

• When assigned on a study, get access to the system and verify the general information automatically recorded
• Ensure the study team contacts are properly recorded in the study platform
• Upload the data provided by the CRO when there is no automatic flow in place (i.e non SSP CROs)
• Verify the data accuracy and report to CML/CPM for corrective actions by CROs

Other missions to the position

• Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes
• Coordinate the writing of articles related to the clinical study or working groups to be posted in the monthly newsletter
• Provide support to the medical writer within the Clinical Study Report (CSR) to secure the collection of appropriate appendices such as investigators’ Curriculum Vitae, list of Ethics Committee & List of participating investigators

EHS responsibilities:

• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

#LI-Hybrid

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.