Denmark
I bring 24 years of experience in the pharmaceutical and CRO industry, with a strong focus on Study Start-up within Clinical Operations. Throughout my career, I have gained deep insight into sponsor–CRO collaboration and oversight processes — including quality expectations, documentation standards, and operational governance. Since August 2023, I have worked as a Study Start-up Specialist at ICON, supporting J&J Innovative Medicine. My expertise includes site activation, regulatory submissions, and cross-functional coordination within the framework of GCP and the EU Clinical Trials Regulation (EU-CTR). With previous leadership experience in Study Start-up, I am passionate about optimizing processes, ensuring compliance, and fostering transparent collaboration across teams and partners. Alongside my professional path, I am a trained facilitator in Family Constellations, Yoga, MediYoga, and Ayurveda — practices that reflect my deep commitment to holistic well-being and self-awareness. This understanding of human dynamics enriches my approach to teamwork, communication, and leadership. Core Expertise: Clinical Operations Specialist | Study Start-up, EU-CTR & Process Excellence | Driving Quality, Collaboration & Continuous Improvement Holistic Practices (Personal Interest): Family Constellation facilitation | Yoga & MediYoga | Ayurveda | Inner transformation
EU-CTR submissions and Informed Consent Specialist
Assisting senior management in managing work and teams within a specific broad area of site start-up, such as site activation, regulatory/ethics submission, site contracts and life cycle maintenance activities in Denmark, Finland, Norway and Sweden. Ensuring fulfillment of customer requirements and compliance with related regulations. Analyzing processes to increase efficiency. Performing operational level planning, including efficient allocation of resources within the department.
Acting SSU Manager (Denmark): Assisting senior management in managing work and teams within site start-up, such as site activation, regulatory/ethics submissions, site contracts and life cycle maintenance activities. Ensuring fulfillment of customer requirements and compliance with regulations. Analyzing processes to increase efficiency. Performing operational level planning, including efficient allocation of resources within the department. Participating in business development presentations as a subject matter expert in site start-up and regulatory functions. Principal Site Start-Up & Regulatory: Responsible and accountable for Danish deliverables for assigned projects. Performing assigned activities that support site start-up activities. Resonsible for training and mentoring of individual Danish team members.
Execute and oversee clinical trial country submissions and approvals for assigned study protocols. Develop local language materials including local language ICFs and translations as well as interact with Ethics Committee and Danish Medicines Agency for assigned protocols. Manage country deliverables, timelines, and results for assigned protocols. Responsible for quality and compliance of assigned protocols. Contribute to development of SOPs. Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements and insurance process management.
Local Submissions Specialist: Acting as the Primary Point of Contact during start-up on allocated projects. Review of essential document packages for site activation and involvement in essential document collection from site. Preparation and submission of EC applications, RA applications, and other local regulatory authorities. Preparation of ongoing submissions, amendments, and periodic notifications required by the EC, RA, and other local regulatory authorities as needed within the country including safety notifications as required by local rules. Country Start-Up Advisor: Acting as Subject Matter Advisor for in-country performance within the site start-up. Provide country-level intelligence on start-up and clinical trial regulatory. Ensure that local country regulatory intelligence, as it pertains to the activities of the local start-up and clinical trial regulatory team, is maintained on the central repository, e.g., RA submissions, EC submissions and notifications to the Danish Data Protection Agency. Responsibility for data protection at country level, provide clear data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Informed Consent template. Provide input in local SOPs and WI. Support for the creation of internal training materials. Provide input to the team to assist with EC, RA or Data Protection issue resolution at the country level. Site Start-up Lead: Acting as site start-up lead for an observational study involving 10 European countries. Managing EC submissions and approvals on European level and being the main point of contact to sponsor in close cooperation with a project manager.
Small company offering both study start-up activities and translation services within the field of medicine. Study-start up actitivies: Preparation of submission packages to the EC (including ICF adaptation, preparation of protocol summary, addendum to protocol and other minor documents to the EC). Translation: Conduction of mainly study related translations of above documents as well as SPCs, package leaflets and marketing campaigns.