Clinical Trials Assistant

Location
Cambridge, MA, United States
Posted
Nov 08, 2018
Ref
R-00320
Hotbed
Genetown
Required Education
High School or equivalent
Position Type
Full time
Title:
Clinical Trials Assistant

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

To assist in the delivery of Clinical Development objectives and achieve Clinical Excellence, by taking responsibility on the TMF and study insurance request management, study Budget & legal/administrative document tracking, CTMS updates, Transparency declarations

To also perform and/or coordinate some specific study activities and assist the Global Clinical Project Manager (GCPM), Clinical Lead (CL) and Clinical Development Program Director (CDPD) on request.

Essential Functions

Trial Master File (TMF) management (External CRO or internal) -
  • Be responsible to set up and administrate the Ipsen eTMF or set up the paper TMF files and to prepare the study specific TMF oversight plan.
  • To maintain and complete the paper and/or electronic TMF for Ipsen documents and appropriate filing documents (See responsibilities in the TMF Procedure)
  • Identify, request and ensure delivery of outstanding and outdated documents from CROs/vendors.
  • Identify and prepare documents for country requirements in the framework of regulatory submissions as needed.
  • Periodically during study course and at the end of the study according to the study eTMF oversight plan, review overall study TMF (whatever format or location e.g. CRO e-TMF/Ipsen e-TMF or paper TMF) for organization, quality, and for completeness as per ICH GCP requirements. Review and QC check of the TMF to ensure their quality and completeness in view of audit or / and inspection or archiving
  • Be responsible to chase up the CRO/vendors and Ipsen teams as appropriate for any missing documents until resolution.
  • Responsible for managing the Archiving of the eTMF


Follow up and review of financial documents, in collaboration with Global Clinical Project Manager (Ipsen or partner GCPM):
  • Create and update financial information within SAP (Internal Order, Purchase order, goods receipt & invoices)
  • Create Commitment Requests within the K2 tool
  • Create and update financial trackers
  • Management of invoices, including review against contracts and study progress for GCPM approval, track and follow up until payment is made
  • Help to prepare forecast and assist at quarterly review meetings of study budget with GCPM and local finance controlling department
  • Complete files for Transparency Office requirements (France, EFPIA, US) or receive and check against study activities in collaboration with the GCPM, and forward files from Service providers and final uploading into Ipsen Transparency Tool (Collect)


Clinical operations activities tracking & coordination:
  • Follow up on execution/signature of Clinical contracts and populate iCap with finalised contracts.
  • Clinical supplies coordination (K2 dispatch order) when there is no IVRS; Internal Meeting preparation and co-ordination
  • Tracking of Ipsen Oversight of a study (e.g. CRO monitoring visit reports...)
  • Study Insurances management: requests, follow-upand renewals
  • Legal administrative documents obtention and follow up as required (POA, LOA, CDA's, Kbis...)
  • Set up, and update of shared study team electronic site (SharePoint or other tool) - Mailing of study documents by express courier, as requested
  • Organising appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...)
  • Assist the GCPM and CL as appropriate and as needed in various study management and monitoring activities, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.


Clinical Trial Management System Data Entry
  • Responsible for data entry and status updates within the CTMS for the assigned studies, with support of the CL or GCPM if needed


Others missions to the position
  • To perform any other activity as may reasonably be required from time to time to ensure the accurate, quality and timely execution of clinical studies
  • To complete all of the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the Ipsen Group


Qualifications

Education & Certifications
  • Ideal: 3-year post High School degree
  • Minimum: 2-year post- High school degree or 3-years of related work experience and training or equivalent combination.

Experience
  • Ideal: Minimum + Experience (or knowledge) of clinical study essential documents and regulatory documents, TMF ; and knowledge of medical terminology is recommended.
  • Minimum: Substantial administrative experience or qualified to degree level.
  • Experience in Clinical Operations area related work is preferred. Scientific background preferred


Core Competencies
  • Ability to work with minimal supervision as well as in a team environment
  • Strongorganizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes:
  • Personal flexibility and a proactive orientation;
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards.


Communication & Interpersonal Skills
  • Written: excellent
  • Verbal: Fluent in English
  • Interpersonal: excellent


Essential Functions - Physical Demands & Working Conditions
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (computer, copy/fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day and occasionally sit or stand or walk for long periods of time
  • Ability to work in a dynamic environment which can include but not limited to office, laboratories, manufacturing, off-site venues, etc. depending on functional role.
  • Standard office environment. Potential interaction with laboratory environment with exposure to chemicals.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 30 pounds.
  • Required to consistently and properly use Personal Protective Equipment in keeping with Ipsen safety policies and practices.


Environmental, Health & Safety Requirements
  • Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EH&S meetings and complete all EH&S training requirements.
  • Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.


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.