Clinical Trial Lead
Aixial in Switzerland is currently hiring a Clinical Trial Lead.
The activities include:
- Author of the clinical study protocol and other study essential documents.
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
- In collaboration with outsourcing/planning/feasibility personnel, representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).
- Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
- Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Regularly update all trial information databases in order to manage accuracy of information.
- Review and approve all study payments as per financial agreements.
- Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
- Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high quality data are transferred/available in a timely manner.
- Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure report is completed according to current requirement. Responsible for report publication;
- A University degree in life sciences (Master, PharmD, PhD)
- Fluent written and oral English
- At least 3 years of relevant experience in clinical trial management (e.g. study management in a multi- national environment using different models for trial execution).
- Demonstrated leadership and problem-solving skills.
- Track record of managing multiple, complex clinical trials.
- Capable of clear written and verbal expression of ideas, an active/proactive communicator.
- Ability to interact with a wide range of people and build strong positive relationships.
- Ability to work independently and in a team environment managing multiple priorities