amcure GmbH is a small biotech company located at Campus North of the Karlsruhe Institute of Technology (KIT) in Eggenstein-Leopoldshafen. The company develops peptide based drugs for the treatment of cancer. The first compound is in advanced preclinical development.
To strengthen our clinical department we seek a
Clinical Development Project Manager (male/female)
As part of the senior staff you are responsible for the operational conduct of assigned clinical trials. You will report to the CEO.
Tasks and responsibilities
Accountable for all aspects of assigned clinical trial(s) including leading Clinical Trial Team(s) (CTT), comprised mainly of external partners and supported by internal staff
Writing of clinical synopses and protocols, Investigators Brochure, ICFs, CRFs, interim study reports and CSR in collaboration with management, internal and external staff
Supervision of and collaboration with selected CRO, strict adherence to budget and timelines
Participation in CRO/vendor/sub-contractor selection
Assurance of highest standards in trial performance and data acquisition
15-20% travel time (site visits, CRO visits)
PhD (life sciences) or MD with at least five-year professional experience in a senior level in clinical development of pharmaceutical or biotech industry (work experience in an SME environment preferred)
Experience in working under GCP, experience in development of a clinical SOP system, basic knowledge of regulatory requirements for clinical trials and in pharmacovigilance are prerequisites
Accurate and team-oriented working in a matrix structure in an interdisciplinary, international environment
Excellent oral and written communication skills in English, in depth knowledge of office software and clinical trials databases are required. Basic knowledge in statistics will be an additional plus.
Excellent and firm communication with external partners (CRO)
Self-initiative, convincing expertise, confidence and collaborative working style are key personal assets.
We offer multi-disciplinary work in a team-oriented start-up environment with short communication channels and promising career opportunities.
Have we inspired your interest? Please send your significant application with your salary requirement and the earliest day of start preferably via email to firstname.lastname@example.org or to amcure GmbH, Dr Matthias Klaften, Hermann-von-Helmholtz-Platz 1, 76344 Eggenstein-Leopoldshafen, Germany
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