Madalina Gramada Email & Phone Number

Romania

• Performs all aspects of in-house site management in accordance with good clinical practices and SOPs. Conducts regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities and to determine protocol and regulatory compliance and prepares required documentation. Documents and helps follow to resolution, issues noted during site management contacts.• Escalates to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines. Serves as the primary study contact for sites, responds to ad-hoc site requests for assistance, provide guidance and assists sites with the resolution of outstanding data queries.• Perform ongoing remote data review, assess for completeness of data and any observed protocol or GCP deviations/violations. Proactively contribute to site audit readiness through back-activities.• Provides site training, ensures study systems are updated study agreements and to ensure adequate communication to project team and sponsor. Play an active role within the clinical team to help reach project milestones, achieve deliverables, and meet project deadlines.

Brasov

Braşov, România

Braşov, România

Braşov, România

Braşov, România

Bachelor'S Degree, Pharmacy

Bachelor'S Degree, Mathematics & Computer Science