DATA MANAGER (permanent contract/full-time job)
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, manufacturing and 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 Statistics & Data Management department in Lugano we are looking for a:
DATA MANAGER (permanent contract/ full-time job)
- Coordinate and supervise the activities of defining the CRF (Case Report Form) in accordance with Helsinn Healthcare CRF Library, Data Validation Plan, Data Management Plan (generally outsourced to CROs). In case of electronic CRF or electronic Diary (eCRF / eDiary) test its functionalities
- Review all the Data Management documents (e.g. Data Management Plan and Data Validation Plan).
- Coordinate and participate in the activities of Computer System integration and test its functionalities (e.g. IRT and eCRF; eDiary and eCRF).
- Participate in defining the raw data dataset structure (SDTM) in accordance with Helsinn Healthcare Database Library and CDISC standards and coordinating activities with CRO data management.
- Review the collected clinical data throughout the conduct of the study in order to ensure that data cleaning activities are carried out consistently and thoroughly.
- Participate to the Blind Data Review Meeting.
- Oversee the activities performed outside the company (CRO) in respect to budget and timelines
The successful candidate has the following qualifications:
- 3-5 years of operational experiences and technical expertise in data management department of a pharmaceutical company or in a CRO
- Knowledge of CDISC Standards are required
- Basic knowledge of SAS system
- Knowledge of English language is essential, so as the informatics tools
- Willingness to travel and also availability to travel outside the usual place of work, namely outside Company’s headquarters
- Analytical skills, accuracy and synthesis
- Ability in team working
- Ability to interact with external consultants and CROs as well as with all other business functions.
Helsinn Healthcare SA is offering attractive conditions and a pleasant working environment in a highly motivated team.
Please send relevant application with CV to: