Clinical Trial Coordinator in München bei Alira Health

Alira Health

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

As Clinical Trial Coordinator, you will work within our Clinical Operations department on multiple projects, supporting the clinical research team in ensuring the most effective and efficient conduct of clinical research studies by providing administration and work alongside the Clinical Project Manager to deliver the highest quality of outputs and customer care.

KEY RESPONSABILITIES

To be familiar with ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.
To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if applicable.
To provide general administrative support to the Project team and assistance to Clinical Project Manager(s).
To set up, organize, track and update clinical trial documentation both in paper form (if required) and in electronic form.
To collaborate with Quality Assurance to ensure that each activity is compliant with internal SOPs and appropriate regulation.
To contact clinical sites for specific requests (e.g. enrolment updates, missing documentation, meeting arrangements, etc).
To support the Study Start-Up Team and CPM with regulatory activities for submission/authorization of a clinical trial.
To act as mentor and supervisor of more junior resources.

DESIRED QUALIFICATION & EXPERIENCE

Degree in life science, pharmaceutical, biology or related field.
Preferred but not mandatory: 2-3 years experience as a Clinical Trial Assistant or related experience will be considered a plus.
Mandatory experience in Regulatory Submission of clinical trials;
Mandatory Experience in TMF Management (also preferred e-TMF);
CRO/Pharma/Health care work experience

TECHNICAL COMPETENCES & SOFT SKILLS