Clinical Trial Associate

Cambridge, MA, United States
Mar 18, 2021
Required Education
Position Type
Full time
Clinical Trial Associate

Ipsen Bioscience, Inc.

Job Description:

Are you looking for an opportunity to apply your clinical operations experience in the oncology therapeutic area?

As Clinical Trial Associate (CTA), you will assist and provide support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies and execute tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking. As CTA you will be responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU). Additionally, you will be responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures while liaising with service providers in regard to Ipsen e-TMF process and resolving issues related to missing documentation.

Your role will involve:

Be responsible for setting-up, 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.
  • Inform the appropriate role of all study team members (CRO/Ipsen) newcomers or departure.
  • Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
  • Perform continuous oversight of the CRO/Ipsen TMF activities, in 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.
  • In charge of archiving the TMF

Be 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 (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
  • 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
  • Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to quarterly review meetings

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.

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 (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes
  • Ensure the study team contacts and handovers are properly tracked in eCTMS
  • Provide the excel tracker to the CRO together with instructions to get all the necessary information monthly to feed the Ipsen eCTMs (Hermès)
  • Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable)

Coordinate and conduct in-house and external clinical operations activities
  • Generate contract templates within the Ipsen dedicated system (i-CAP), 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), Kbis…
  • Ensure insurance certificate and renewals are being requested prior to the study start-up and during the course of the study
  • 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
  • Set-up and maintain shared study electronic site (SharePoint, box or other tools)
  • Organize appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...) such as Investigator's meeting, DRM & TFLs, Steering Committee, …
  • Attend all study team meeting when appropriate and take meeting minutes
  • 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

In return, you will bring:
  • Experience in clinical study environment within CRO or Pharmaceutical company.
  • Knowledge of the clinical study environment with a strong theoretical or practical administrative organization.
  • Scientific background is an asset.
  • Degree in a scientific, or clinical or research field and a 1 minimum of 1year relevant work experience in a clinical research/study management environment (academia or pharma or CRO).
  • Minimum: 2-year relevant scientific focused degree and a minimum of 2 years relevant work experience within clinical research /study management environment

If this sounds like an exciting opportunity to work on a global oncology clinical operations team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.