Clinical Trial Administrator

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.

Knowledge & Experience

Essential:

• 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 theoretical or practical administrative organization.

Education / Certifications

Ideal: 3-year degree in an administrative or scientific domain
Minimum: 2-year degree of related work experience and training

Languages

English is the working environment; strong English intermediate level is necessary. Good written and oral understanding is necessary for the position.

Pay & Benefits

• Annual base salary range: $67,500-$99,000
• Eligible to participate in short-term incentives program
• Comprehensive employee benefits package including: 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, flexible spending accounts, parental leave, paid time off, discretionary winter shutdown, well-being allowance, commuter benefits, and more
• Individual compensation within the posted range depends on factors including prior education and experience, job-related knowledge and demonstrated skills