Clinical Trial Leader II , Schweiz Michael Bailey Associates - MuniHELP
|Beschreibung:||Clinical Trial Leader II|
|Firma:||Michael Bailey Associates - Muni - Firma bewerten|
|Salär:||zu verhandeln CHF - 40 Std/Woche|
We are recruiting for a Clinical Trial Leader who will be responsible for the management and execution of clinical trials within Translational Medicine (TM). Your functions as a CTL would involve the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards. This is an 18 month contract position.
- Responsible for leading and Matrix managing the multidisciplinary Clinical Trial Team and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
- 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.
- Identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meetings
- Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived appropriately.
- Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.
- Review and approve all study payments as per financial agreements.
- Train, support and regularly 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 to ensure high quality data are transferred
- Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.
- Provide CS&I expert advice to other departments and line functions (eg CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.
- Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.
- Responsible for the availability of high quality, Translational Medicine data according to agreed timelines and budget to enable no delays in decision making and drug registration.
Ideally PhD in Lide Sciences, Pharm D. BSc or MSc is also acceptable when paired with robust experience.
- Relevant experience (5+ years) in clinical trial management
2) Study management in a multi- national environment using different models for trial execution.
3) Demonstrated leadership and problem-solving skills.
4) Track record of managing multiple, complex clinical trials.
5) Great communication skills; capable of clear written and verbal expression of ideas
6) Ability to interact with a wide range of people and build strong positive relationships.
7) Potential for customer orientation awareness and focus.
Please send CVs or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
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