Clinical Trial Leader/ Operations Manager (Phase I )
As an ideal candidate you should have 5+ years of experience in Clinical Trial management in a multi- national environment using different models for trial execution. As a Clinical Trial Leader/ Clinical Operations Manager, you will be responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Furthermore, you will act as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/ SOPs).
- Author of the clinical study protocol and other study essential documents;
- Ordering and management of clinical trial materials, including drug supplies and CRFs;
- In collaboration with all stakeholders, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s), 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;
- Ensure the set up and maintenance of the Trial Master File for assigned studies according to the appropriate guidelines;
- Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards;
- Regularly update all trial information on databases and review/ approve all study payments as per financial agreements;
- Interact with Investigator sites and service provider to ensure smooth study set up and excellence of study conduct;
- Assist in data review and interactions with the Data Manager, Statistician, and third parties 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 and finally responsible for report publication.
Qualifications and Experience:
- Demonstrated leadership and problem-solving skills;
- Track record of managing multiple, complex clin- ical 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;
- Potential for customer orientation awareness and focus;
- Excellent organizational skills and interpersonal skills;
- Fluent in English essential, German or French advantageous;
- Relevant working/residency permit or Swiss/EU-Citizenship required.