Site relationship management role ensuring sustainable trial start - up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
TS
Hybrid Senior Clinical Research Associate I/II – Senior Klinischer Monitor
Posted 2 months ago
About the role
- Senior Clinical Research Associate managing clinical trials for Thermo Fisher Scientific in Germany. Conducting site monitoring, ensuring compliance, and maintaining data accuracy across multiple locations.
Responsibilities
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
- Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
- Ensures audit readiness.
- Develops collaborative relationships with investigational sites.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Requirements
- Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
- Valid driver's license.
- Full Right to work in Germany.
- Fluency in English and German language to at least C1 level (note that the interview will be held in German).
Benefits
- Severely disabled applicants with the same aptitude will be given preferential treatment.
- Reasonable accommodation to participate in the job application or interview process.
- Administrative tasks such as expense reports and timesheets in a timely manner.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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