Clinical Project Manager
vor 3 Wochen
Description
Function Clinical Project Manager (CPM)
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
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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