Beschreibung
Hays ist ein weltweit f�hrender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl f�r den Projekteinsatz als auch f�r Festanstellungen und auf Zeit. In Deutschland, �sterreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualit�tsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Clinical Trial Leader II (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Basel region
Branche: Vermittlung von Arbeitskräften
Ihre Aufgaben:
- Accountable for the writing of clinical protocols and related documents in collaboration with the Clinical trial Team: lead the clinical trial protocol development process; contribute to the operational and scientific input given for the development of trial-related documents and processes which reside in other line functions
- Lead and matrix manage the global multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
- Function as a Lead CTL on studies for Full Development and assist in the coordination of TM related submission documents
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
- In collaboration with CRO management, Clinical Trial Team and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting
- Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility
- Responsible for set up and maintenance of the Trial Master File for assigned studies
- Regularly update all trial information databases in order to manage accuracy of information
- Approve for all necessary center payments as per financial agreements
- In collaboration with the Clinical Trial Team, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/external presentations
- Coordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved
- Contribute to identification and evaluation of new centers suitable for performing studies in healthy volunteer and patients
- Responsible for implementation of best practices and standards for trial
- Contribute to talent and career development of staff through active participation in on-boarding, training and mentoring activities
Ihre Qualifikation
- BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background
- Fluent English (oral and written), knowledge of a second language is desirable
- Gained relevant experience in Translational medicine, Clinical Research or Research Nurse experience (CRO, academic institution, hospital or industry), as judged from CV/interview
- Potential to cope with both scientific aspects and operational tasks in a multidisciplinary organization (team-work)
- Knowledge of drug development process
- Capable of clear written and verbal expression of ideas
Skills:
- Clinical Project Management