Clinical Project Manager (CPM)
Description
Function
Clinical Project Manager (CPM) Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne Write an email Percentage
100 %
Reporting Line
Head of Clinical Operations (HCO) Company Profile
Required:
Function
Clinical Project Manager (CPM) Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne Write an email 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 The Clinical Project Manager will be responsible, under the supervision of
- Manage international clinical studies according to time, cost and quality standards
- Negotiate, implement and maintain contracts with study partners
- Manage activities of study partners, support clinical CRO in managing the sites
- Review and approve submission packages for submission to Ethics
- 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
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
- 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
À propos de l'entreprise
CH-1015 Lausanne / Lausanne
