CRM is primarily accountable for the study oversight; end to end performance, compliance with ICH/GCP and country regulations, Client policies, requirements internally and externally and leading team meetings. Review and approval of monitoring visits reports. Performing Clinical Quality Visits to sites. Responsible for studies in up to 7 countries.

Responsible for performing and coordinating all site and protocol activities including monitoring process in accordance with ICH-GCP and Global SOPs to access the safety and efficacy of investigational products. Conducts the sites to determine protocol and regulatory compliance and prepare required documents. Performing site management for the responsible sites in each protocol.

Site management. Phase I studies. Responsible for performing and coordinates monitoring process in accordance with GCP and Global SOPs to access the safety and efficacy of investigational products and medical devices. Conducts the sites to determine protocol and regulatory compliance and prepare required documents.

Responsible for performing and coordinates monitoring process in accordance with GCP and Global SOPs to access the safety and efficacy of investigational products and medical devices. Conducts the sites to determine protocol and regulatory compliance and prepare required documents.

Performs and coordinates all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions and ancillary documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study.  Performs co-monitoring with junior CRAs.

Part of the Clinical Start-Up Team at PPD.

Responsible for the coordination, review and approval of all legal documents in a specific project for all involved countries.

Responsible for all contract and budget negotiation in Denmark.

Complete and review all legal documents used for clinical activities at PPD Denmark.

Performs and coordinates all activities required to finalise Statement of Agreement and financial agreements with investigative sites, pharmacies, laboratories and other relevant contractual parties. Performs co-monitoring with junior CRAs.

Responsible for all submission activities in Denmark. Updates on legal activities, including training of all Danish staff, updating templates and contact person for authorities in Denmark.

Certified to conduct Accompanied Field Visits (AFV) to provide ongoing training, evaluation and development of the CRAs.

Certified to conduct Accompanied Field Visits (AFV)

Responsible for conducting studies in Denmark, all phases and categories.

Including: Project Manager (PM): Responsible for trial conduction of different studies according to ICH/GCP, incl. submission to the regulatory authorities + CRA: Responsible for monitoring procedures according to ICH/GCP Guidelines. Upstart and training of new established site in Cape Town, South Africa. Worked as PM reporting to University of Cape Town.

AstraZeneca Denmark A/S, Albertslund.

Worked with both GPs, Private clinics and hospitals in Nordic countries. Had responsibility for training of study coordinators in ICH-GCP.