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Clinical Trial Leader
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support
Projektbeschreibung
We are recruiting for a Leader in Clinical Research (Translational Medicine) who will provide their expertise in collaboration with physicians to support clinical research efforts in multiple therapeutic areas. You will be responsible for the management and clinical execution of assigned clinical trials within Translational Medicine. 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.
Responsibilities:
* Responsible for leading clinical Matrix teams and support functions to ensure protocols and clinical development plans for clinical studies are developed accurately.
* You will be responsible for the budget.
* Experience as a medical writer in drafting and writing clinical trial documents such as IND, brochures, regulatory submissions for FDA, EMA, Reports etc.
* Responsible for the availability of high quality, study data according to agreed timelines and budget to enable no delays in decision making and drug registration.
* Responsible for study concept for exploratory clinical development plans,
* 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
Requirements
Education:
Ideally PhD in Life Sciences, Pharm D. BSc or MSc is also acceptable when paired with robust experience.
Experience:
1. Relevant experience (5+ years) in clinical research with 3+ years in drug development (preferably oncology drug development experience)
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.
Responsibilities:
* Responsible for leading clinical Matrix teams and support functions to ensure protocols and clinical development plans for clinical studies are developed accurately.
* You will be responsible for the budget.
* Experience as a medical writer in drafting and writing clinical trial documents such as IND, brochures, regulatory submissions for FDA, EMA, Reports etc.
* Responsible for the availability of high quality, study data according to agreed timelines and budget to enable no delays in decision making and drug registration.
* Responsible for study concept for exploratory clinical development plans,
* 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
Requirements
Education:
Ideally PhD in Life Sciences, Pharm D. BSc or MSc is also acceptable when paired with robust experience.
Experience:
1. Relevant experience (5+ years) in clinical research with 3+ years in drug development (preferably oncology drug development experience)
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges