CLINICAL RESEARCH MANAGER
Main responsabilities and tasks
- Design, planning, coordination and implementation of preclinical and clinical studies (phase I-IV), both directly and through Contract Research Organisations (CROs)
- Contribution in the development of project strategy, including budget definition and monitoring, and clinical development plans
- Execution of study related regulatory procedures (i.e. notification/submission to Regulatory Authorities, including electronic applications, and submission to Ethical Committees) directly or through CROs
- Identification and quality evaluation of research centres and CROs
- Interface and collaboration with Regulatory Affairs Dept., Clinical Data Management and Statistics Dept., pharmaceutical Development Dept., Drug Safety Unit, Clinical Quality Assurance Unit, Marketing Dept
- Planning and writing of study protocols, independently or in cooperation with opinion leaders
- Writing of study related documentation (i.e. Investigator’s Brochure, CRF, patient's information sheet and consent form).
- Evaluation of pre-clinical and clinical data and contribution in writing clinical study reports and scientific publications
- Writing of clinical documentation as required for regulatory authorities submission (eCTD)
- Participation to national and international meetings with affilated companies or distributors
- Participation to scientific advice meetings and preparation of the relevant scientific documentation.
- Development of documentation and presentations for scientific meetings at Regulatory Agencies
- Organisation of meetings and international congresses: contacts with speakers, abstracts, preparation and revision of presentation in collaboration with the congress manager and Marketing Dept.
- Academic degree in Pharmacy, Biology or Pharmaceutical Chemistry
- Good knowledge of English written and spoken
- Previous work experience in the area of competence
- We are looking for an open minded analytical thinking person, which is capable to resolve complex matters, team work oriented and highly motivated
IBSA Institut Biochimique SA in Pambio-Noranco, Ticino, Switzerland
Scientific Research and Development
Laut Paragraph n°1 L.903/77 und n°4 L.125/91 ist diese Anzeige sowohl an männliche als auch weibliche Kandidaten gerichtet.