Clinical Project Manager

vor 3 Wochen

CH Lausanne AC Immune SA Vollzeit

Description
Function Clinical Project Manager (CPM)
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
Percentage 100 %
Reporting Line Head of Clinical Operations (HCO)
Company Profile •AC Immune is a clinical stage Swiss biotech company focused on the
development of innovative therapeutics and diagnostics for Alzheimer’s
and other neurodegenerative diseases

  • 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ
  • AC Immune SA is a progressive, equal opportunity employer

Job description The Clinical Project Manager will be responsible, under the supervision of
the HCO, of the management of regional and/or international studies, alone
or in collaboration with a Lead CPM, according to time, cost and quality
standards.
Key Responsibilities •Manage international clinical studies according to time, cost and
quality standards

  • Negotiate, implement and maintain contracts with study partners
    (study vendors, sites)
  • Manage activities of study partners, support clinical CRO in managing
    the sites
  • Review and approve submission packages for submission to Ethics
    Committees/Institutional Review Boards
  • Supply proper documentation to the Regulatory department for
    submission to Regulatory Authorities
  • Contribute to the generation of SOPs/WIs
  • Participate in clinical study design
  • Create and maintain operational plans
  • Prepare study budgeting and forecasting
  • Global budget management of studies
  • Ensure the accurate planning and ordering of clinical study drug supply
  • Lead study protocol development
  • Write and update clinical study documents
  • Participate to review and approval of the Clinical Trial Report
  • Be responsible for the Trial Master File
  • Participate in study specific core team meetings

Qualifications & Skills Required:

  • A scientific degree is required as well as the ability to work in a start-up
    environment, handling multiple demands and strong planning and
    organizational skills
  • Minimum of 4 years of experience in clinical research (preferably with
    2 years coordinating international or leading regional studies)
  • Knowledge in international standards (GCP/ICH) as well as in
    international (FDA/EMA) and local regulations
  • Hands on experience in writing clinical study documents
  • Good spoken and written English

Personal features include:

  • Advanced understanding of timelines, budget and resource
    management
  • Planning, tracking and solving skills for maintaining project timelines
  • Networking skills
  • Working both independently and in a cross-functional team setting

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