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vor 2 Wochen

Munich, Deutschland Advanced Resource Managers Vollzeit

Are you an experienced Senior Clinical Research Associate with considerable clinical research monitoring experience? Are you based in Germany and looking for a new contract role? If so, we are keen to hear from youOur leading CRO client is recruiting for a Senior CRA to be based in Germany, performing and coordinating all aspects of the clinical monitoring and site management process.This position is offered on a 12 month contract basis initially, working 32 hours per week.Description:Work in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating ProceduresConducts site visits to assess protocol and regulatory compliance and manages required documentation.Responsible for ensuring that data will pass international quality assurance audits.Represent our client in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel.Will assist project manager or clinical team manager on assigned projects and will take a lead role where required.Will support the line manager to mentor, train and contribute to the development of junior clinical team members.Required to travel 60-80% on average.Education and Experience:Degree in a science related field or, a certified health care professional, or equivalent certification/licensure from an appropriately accredited institution.Considerable clinical research monitoring experience with a demonstrated high level of expertise in all aspects of clinical monitoring.Expert clinical monitoring skills.Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures.Skills to mentor and train other monitors in a positive and effective manner.Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology.Proven flexibility and adaptability.Excellent team player with team building skills.Effective presentation skills.Ability to work independently as required.Ability to utilize problem-solving techniques applicable to constantly changing environment.Fluency in English and in the country's native language.Valid Driver's License.

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