Clinical Data Manager (permanent contract/full-time job)

Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.

Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

 

For our  Data Management department in Lugano we are looking for a:

 

Data Manager (permanent contract/ full-time job)

 

Responsibilities include:

 

  • Provide independent leadership for assigned studies and act as primary liaison with CROs and the study team for data management activities. Provide regular status reports to the Head of DM as required, communicate potential risk factors in a timely and appropriate manner.
  • Provide input to protocol design.
  • Review the study budget and timelines for data management activities throughout the life cycle of the assigned studies.
  • Coordinate and supervise data management activities to ensure that study deliverables are achieved on time and to the highest quality, in compliance with international standards and guidelines, as well as Helsinn standards.
  • Support and supervise the development and quality reviews of key study documents such as the Case Report Form, CRF Completion Guidelines, Data Management Plan, Data Validation Specifications, Data Management Report, Study Specific Procedures and Forms, and other documents, as required, in compliance with Helsinn standards.
  • Support and supervise the development, integration and validation of the clinical database and other electronic systems. Perform User Acceptance Testing.
  • Support and supervise all data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database lock, and relevant archiving of study materials.
  • Review the clinical data collected throughout the conduct of the study in order to ensure that data cleaning activities are carried out by the CRO consistently and thoroughly.
  • Support blind data review meetings activities.
  • Support preparation of files and documentation for electronic submission to regulatory agencies.
  • Contribute to departmental SOP and process development and improvement, and integration of technology.

 

The successful candidate has the following qualifications:

 

  • The person should have minimum 7 years of operational experiences and technical expertise in data management department of a pharmaceutical company or in a CRO.
  • Bachelor’s degree in a scientific discipline or equivalent.
  • The technical skills are specific to the data management/pharmaceutical field and guide the operational component of the position.
  • Knowledge of English language is essential, so as the informatics tools.
  • Basic knowledge of SAS system and technology platforms to capture and process data are required.
  • Knowledge of current industry standards such as CDISC (SDTM and CDASH) are required.
  • Demonstrated proficiency managing the lifecycle of clinical data projects.
  • Knowledge of GCP, ICH and regulatory authorities’ guidelines as applicable for Clinical Data Management.
  • Willingness to travel and also availability to travel outside the usual place of work, namely outside Company’s headquarters.
  • Analytical and problem-solving skills, accuracy, and synthesis are required.
  • Ability to work independently and with the team.
  • 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:

http:// helsinn.jobopportunity.ch