**Description:** + 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 Client **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/Client)** 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/Client 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** + 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)** + 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) **Experience/Qualifications Required** + Experience **in clinical study environment** within **CRO or Pharmaceutical company.** + Knowledge of the clinical study environment with a **strong theorical or practical administrative organization.** + **Scientific background** is an asset. + **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** **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.