Clinical Trial Administrator

Ipsen•Cambridge, MA

About The Position

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! WHAT - Main Responsibilities & Technical Competencies Be responsible for setting-up, monitoring, verifying and archiving the clinical Trial Master File (TMF): In charge of the Ipsen TMF (electronic and/or paper, 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 Management plan, & TMF master index, according to the clinical study specificities, with the CPM and the Document Owners. Inform the eTMF Support Team of any modification of the study team structure, e.g. study team members (Internal/External) new arrival or departure. Ensure the TMF is being maintained, kept up-to-date, and all essential documents are appropriately filed. Perform continuous oversight of the Service Provider (SP)/Ipsen TMF activities, according to Ipsen SOP. Coordinate the TMF Quality Check (as per Ipsen SOP) with the SP/Ipsen to maintain data integrity and to ensure eTMF inspection/audit readiness. Present the results of the Quality Check to SP and to study team. For all findings, ensure that corrective actions are performed according to defined timelines. Coordinate the final TMF reconciliation with the CPM and the study team. In charge of archiving the TMF according to paper TMF/e-TMF SOP. Escalate any TMF critical issues to CPM/Managers of Clinical Operations. Be responsible for follow-up and review of financial documents, in collaboration with CPM: Track invoices against SP/Vendor contracts and study progress to provide recommendation of approval (or otherwise) to the CPM. Support in initiation of Purchase Orders, in finance system, if required. 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 . Ensure complete data tracking by the SP with the Data Collection Template (DCT). Check the data received from the SP. Ensure the information is properly recorded in the Data Transparency system (COLLECT), implement corrective actions where needed. Ensure the transfers of value collected (directly or via the SP) 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 is to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system. Responsible for status updates within the clinical study tracking systems: When assigned on a study, get access to the study records and update study tracking systems (e.g. eCTMS or other tools, as specific to study) as applicable (at study/region/site level: e.g. status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CPM. Provide trackers/templates to the SP, together with instructions on how to get all necessary information to update the Ipsen clinical study tracking systems/tools. Update the clinical study tracking systems/tools monthly with the SP tracker information after validation with the CPM . Undertake data entry to the clinical study tracking system if required (e.g. if automatic upload of information is not possible). Ensure the study team contacts and handovers are properly tracked. Coordinate and conduct in-house and external clinical operations activities: Generate contract templates within the Ipsen dedicated system (ARIBA), follow-up 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 Authorization (LOA), Confidentiality Disclosure Agreement (CDA). Ensure insurance certificate and renewals are being requested prior to the study start-up and during the course of the study. Provide support to the medical writer with 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. Set-up and maintain shared study electronic site (SharePoint, or other tools). Organize appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order etc) such as Investigator’s meeting, DRM & TFLs, Steering Committee. Attend study team meeting when appropriate and take meeting minutes for team review.

Requirements

Minimum 4 years related professional experience
Experience in global clinical study environment within SP or Pharmaceutical company
Knowledge of the clinical study environment with a strong theorical or practical administrative organization
Ideal: 3-year degree in an administrative or scientific domain
Minimum: 2-year degree of related work experience and training
English is the working environment; strong English intermediate level is necessary
Good written and oral understanding is necessary for the position

Responsibilities

Be responsible for setting-up, monitoring, verifying and archiving the clinical Trial Master File (TMF)
Be responsible for follow-up and review of financial documents, in collaboration with CPM
Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force
Responsible for status updates within the clinical study tracking systems
Coordinate and conduct in-house and external clinical operations activities