Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)
Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regards Ipsen e-TMF process and resolving issues related to missing documentation
Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection
Contributes to clinical trial excellence initiatives
Main Responsibilities And Tasks
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.
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 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)
Organise 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
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
Experience
Experience / Qualifications
Ideal: experience in clinical study environment within CRO or Pharmaceutical company.
Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
Scientific background is an asset.
Qualification
Ideal: 3-year 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
Language
English: Strong intermediate level
Key Required Technical Competencies
Ability to work in a strong regulated environment within a quality management system (QMS)
Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …)
Ability to organize and prioritize
Able to produce work in teams and within a multi-disciplinary environment
Basic Financial Knowledge- must be able to work with financial tracking tools
Knowledge of Pharmaceutical Industry R&D
Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations
The annual base salary range for this position is $65,250-$95,700.
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a 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, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet News
Referrals increase your chances of interviewing at BioSpace by 2x