CRO OUTSOURCING (Temporary Contract)
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology.
In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.
For our Clinical Research Division in Lugano we are looking for a:
- Main point of contact for CROs and other providers of clinical trials services
- Management of introductory meetings, maintenance of CROs database, etc.
- Management and coordination of the process leading to the selection of the CROs to which outsource the Clinical Research & Development managed projects in close collaboration with CRD colleagues as well as with the project team: identification of potential candidates, preparation of request for proposal packages, review of proposals and cost estimates, organization of b.i.d defence meetings, writing CRO selection reports etc.
- Management of contract negotiations with the CRO until contract execution. Coordination of contract revision by internal functions and mainly:Helsinn Legal and Financial division
- Negotiation and finalization of Change Orders and other relevant contract amendments
- Management and coordination of the review process of Clinical Trial Agreements negotiated by the CRO with sites and Investigators in collaboration with Helsinn Legal division
- Management and coordination of the preparation of other legal documents needed for clinical trials such as:Indemnification Letters, etc.
- Supporting Clinical Research & Development (CRD) officers in the management of the study budget and change orders of individual CRD managed projects according to contractual agreements
The successful candidate has the following qualifications:
- Approximately 5 years in similar positions in Pharmaceutical Companies and/or international CROs
- University degree
- Excellent knowledge of written and spoken English
- Proficient use of standard of IT tools
- Availability to travel
- Analytical skills, accuracy and synthesis capabilities as well as organizational skills
- Excellent relations with colleagues and functions outside the company, ability to work in teams as well as independently
Helsinn Healthcare SA is offering attractive conditions, a pleasant working environment in a highly motivated team and a long-term perspective.
Please send relevant application with CV to: