Ronja Forsten-Kaufmann

via CRO Oriola and Direct

• Led and coordinated anonymization and publication of clinical data per various transparency regulations (EU CTR, Health Canada, EU PASS, NIH Final Rule as well as other ad hoc requests).
• Acted as responsible person for ruleset, oversaw workflow, resources and coordinated tasks.
• Delivered internal presentations, trainings and regulatory briefings to ensure alignment across functions on evolving regulatory obligations and timelines.
• Effectively collaborated with health authorities, vendors and cross-functional study teams to achieve project submission goals effectively and on time, promoting a cooperative and productive environment.
• Vendor management: contact point, contract discussion participation as well as billing processes to align deliverables with budget and scope.
• Led initiatives, acted as SME, implemented new processes, updated SOPs, and onboarded new team members.
• Protected Personal Data (PPD) expert, Commercial Confidential Information (CCI) strategy and review facilitator.
• Identified opportunities for process improvements and implemented cost-saving solutions through streamlining workflows and eliminating redundant steps.

• Completed Master’s thesis on improving writing of submission documents (focus on eCTD Module 2).
• Conducted detailed quality control reviews of clinical documents, ensuring structural accuracy, data consistency, and compilation in eDMS while compliant with local and global regulatory standards.
• Maintained strong communication with global teams to meet deadlines.

Part-time work

• Helped patients understand their medications by explaining medical and pharmacological information in a clear, relatable way.
• Provided one-on-one counseling to support treatment adherence and ensure patients felt confident managing their health.
• Gained hands-on experience in patient communication, education, and promoting safe medication use.

Freelance