Clinical Trial Manager
Position
Clinical Trial ManagerRegion
Basel-LandschaftDauer
12 months Positionsnummer
TA1200618012024Aufgaben
- Providing the medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
- Delivering the medical aspects of the Clinical Project Development Plan related to the indication and overseeing its implementation
- Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents
- Supporting the Clinical lead by contributing to global strategic development and providing evidence-based input to clinical project-related, strategic and regulatory documents
- Writing protocol amendments and other study related documents such as the Informed Consent Form (ICF), committee(s) charter(s), subject narratives and the Clinical Study Report (CSR)
- Delivering medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
- Interpreting Clinical Trial data and present conclusions and action plan(s) to Clinical Development Management team
- Managing contacts with external Experts, National Coordinating Trainers (NCTs) and study site investigators.
- Answering to trial-related EC/IRB and HA questions
- Developing a sound understanding of the science and medicine relating to the therapeutic area.
- Developing a sound understanding of the complexity of global clinical development with an attention to methodological and ethical aspects of development, in the assigned therapeutic area.
- Performing literature reviews and write position papers as necessary
- Delivering medical training to the study teams’ members and/or Idorsia staff and protocol-related training to study sites.
Qualifikationen
- Medical Doctor
- At least 2 years’ experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia preferably within cardiovascular therapeutic area
- Experience in patient education is a plus
- Good knowledge of drug development and clinical trial process based on previous experience
- Good knowledge of regulatory requirements/ICH guidelines
- Good organizational and communication skills, able to work as part of a team and independently
- Proven record of successfully engaging and interacting within a complex and challenging matrix organization as well as with all levels of seniority
- Results driven attitude and good sense of urgency
- Able to anticipate and proactively address issues and demands, solution oriented and hands-on
- Analytical thinking, data and detail oriented
- Shares knowledge and expertise openly
- Excellent written and spoken communication skills in English
About the company
