Clinical Trial AdministratorIPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.

• Employee Care: We care for our employees, who are the ambassadors making a real difference.

• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.

• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

The Clinical Trial Administrator assists in the delivery of Clinical Development objectives and achieve Clinical Operation Excellence, mainly by supporting the Clinical Research Manager (CRM)/Clinical Project Manager (CPM) in administrative activities within the conduct of the clinical studies

Main Responsibilities

• Perform and/or coordinate, on request, some non-administrative specific clinical study tasks under the direction of the CRM/CPM and Program Director/Head of ClinOps

Be responsible for settingup, monitoring verifying and archiving the clinical Trial Master File (TMF)

• In charge of the Ipsen electronic TMF (and/or paper TMF, if applicable) set-up and administration.

• Manage the clinical study creation and set-up for the country and site binders and the trial milestones.

• Prepare and customize 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. protocol.

Be responsible for followup and review of financial documents, in collaboration with CRM/CPM

• Create and update financial information within the Ipsen financial system (K2, SAP, …) (Internal Order, Purchase Order, goods receipt & invoices), or managed by a dedicated position, if available.

• Create and follow-up of the clinical study Commitment Requests within the Ipsen dedicated tool (K2).

• Create and update the specific clinical study budget trackers.

• Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM.

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.

Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)

• When assigned on a study, get access to the study record in eCTMS.

• Check the eCTMS study data using the Clinical Operations Reporting (with the support of CRM/CPM for the monthly report purposes.

Coordinate and conduct in-house and external clinical operations activities

• Generate contract templates within the Ipsen dedicated system (i-CAP), followup until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts.

• Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorisation (LOA), Confidentiality Disclosure Agreement (CDA), Kbis…

Qualifications

• Bachelor's life science degree or administrative

• Strong experience in clinical study environment within CRO or Pharmaceutical company.

• Knowledge of the clinical study environment with a strong theorical or practical administrative organization.

• English fluency

• Computer literacy

• Ability to travel as required with the needs of the role, up to approximately 25% of the time.

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