Job Detail

Senior Clinical Project Manager

Description
Function Senior Clinical Project Manager (Senior CPM)
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
Percentage 100 %
Reporting Line Group Leader Clinical Operations (GLCO)
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

• 140+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ


• AC Immune SA is a progressive, equal opportunity employer

Job description The Senior Clinical Project Manager is responsible, under the supervision of
the GLCO, of the management of international and/or complex studies
according to time, cost and quality standards.
Key Responsibilities •Manage international and/or complex 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 and share experience and
  expertise when reviewing documents created by other members of the
  clinical team


• 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


• Serve as a mentor and as a dedicated point of contact for operational
  related questions for junior team members within the clinical team

Qualifications & SkillsRequired:

• Minimum of 6 years of experience in clinical research (with 4 years
  coordinating international or leading regional studies)


• Previous monitoring experience and knowledge in international
  standards (GCP/ICH) as well as in international (FDA/EMA) and local
  regulations


• Hands on experience in writing clinical study documents


• 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


• Personal features include:
  o Advanced understanding of timelines, budget and resource
  management
  o Planning, tracking and solving skills for maintaining project
  timelines
  o Networking skills

Senior Clinical Project Manager

o Working both independently and in a cross-functional team
setting
o Good spoken and written English are required