Mariann Friis-Ottessen
Clinical Research Associate
Oslo
Summary
Biologist with a PhD and nearly 10 years of experience driving clinical operations across oncology, Alzheimer’s disease, acute medicine, hematology, rare diseases, cardiovascular disease, and MASH.
Skilled in leading cross-functional collaboration, operational planning, timeline execution, risk mitigation, and quality oversight within highly regulated environments.
Overview
10
10
years of professional experience
5
5
Certifications
3
3
Languages
Work History
Clinical Research Associate II
ICON plc /Novo Nordisk Norway
08.2022 - Current
- Conducted clinical trials in accordance with protocol and recorded and monitored progress.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements and ICH-GCP.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Assessed safety reporting requirements, ensuring proper documentation and notification procedures were followed consistently.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Monitored safety of subjects and oversaw consent procedures to comply with local and federal regulations.
- Implemented new technologies in the management of clinical trials, streamlining data collection and reporting processes.
Clinical Research Associate
Manpower – ICON DOCS /Novo Nordisk Norway
05.2021 - 08.2022
- Supported project delivery for Alzheimer’s disease study, maintained operational oversight, and enabled effective communication pathways.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Contributed to the development of study documents, including informed consent forms and case report forms.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
GCP Advisor & Clinical Research Associate
Oslo University Hospital
12.2015 - 05.2021
- Oversaw compliance, supported clinical project governance, performed risk assessments, and trained cross-functional teams.
- Maintained up-to-date knowledge on industry trends and regulations, ensuring accurate advice was provided to clients at all times.
- Developed long-lasting relationships with clients.
- Mentored junior advisors, fostering a supportive team environment focused on growth and learning.
Education
Ph.D. - Basic Medical Sciences (Oncology & IBD)
Oslo University Hospital
University Of Oslo 04.2001 -
Master of Science - Genetics
Norwegian University of Life Sciences
Norwegian University Of Life Sciences 04.2001 -
Bachelor of Science - Biotechnology
Norwegian University of Life Sciences
Norwegian University Of Life Sciences 04.2001 -
Skills
Clinical Project Management
Cross-Functional Leadership
Vendor & Stakeholder Management
Operational Planning & Timeline Ownership
Risk-Based Monitoring & Mitigation Strategies
Compliance, Quality & Inspection Readiness
Certification
ICH-GCP E6 (R3), Novo Nordisk (2025)
Key Project Management Contributions
- Coordinated operational activities for multiple global clinical trials with cross-functional dependencies.
- Executed risk-based monitoring strategies and ensured inspection readiness.
- Led multi-year PhD research project including planning, execution, reporting, and stakeholder communication.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Clinical Research Associate II
ICON plc /Novo Nordisk Norway
08.2022 - Current
Clinical Research Associate
Manpower – ICON DOCS /Novo Nordisk Norway
05.2021 - 08.2022
GCP Advisor & Clinical Research Associate
Oslo University Hospital
12.2015 - 05.2021
Ph.D. - Basic Medical Sciences (Oncology & IBD)
Oslo University Hospital
04.2001 -
Master of Science - Genetics
Norwegian University of Life Sciences
04.2001 -
Bachelor of Science - Biotechnology
Norwegian University of Life Sciences
04.2001 -