Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
Excellent organizational and time management skills
Skills to handle multiple priorities and to work with deadlines and under pressure
Excellent written and oral communication skills
Skills to coach and mentor other clinical staff
Fluent in written and verbal English and German
Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;
Assists in Business Development activities
May have supervisory functions in clinical projects
May be required to train, coach and supervise junior staff
May be required to train, coach, and supervise junior staff
Qualifications
Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;
Assists in Business Development activities
May have supervisory functions in clinical projects
May be required to train, coach and supervise junior staff
May be required to train, coach, and supervise junior staff
