Description
Function
Clinical Project Manager (CPM) Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben 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 Head of Clinical Operations, of the management of regional and/or international studies, alone or in collaboration with a senior 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