Oversaw clinical trials, led cross-functional teams, and provided clinical operations expertise to ensure high quality project delivery within established timelines and budget.- Supported the completion of a cardiovascular phase III registration study and the NDA and MAA submissions, ensured inspection readiness - Supported a large cardiovascular outcome study during the recruitment phase- Supported a post approval study during the recruitment phase - Supported an early clinical project during the initial planning and set-up phase

- Lead and supervised all operational activities for a cardiovascular phase III registration study during planning, set-up and conduct phase- Line manager of the assigned operations team

Led complex phase I/Ib studies with 100+ patients during all study phases:- Led and matrix managed the cross-functional Clinical Trial Team to ensure all trial deliverables were met according to timelines and budget - Wrote, reviewed and updated study and related documents (clinical protocols, amendments, informed consents, clinical study reports, etc.)- Contributed to clinical sections of regulatory documents (investigators brochures, replies to Health Authorities and EC/IRB questions, annual safety reports)- Investigator/site relationship management- Performed protocol trainings and site initiation visits- Scientific data review and cleaning- Prepared and run dose escalation meetings with investigators. Coordinated the real time availability of quality clinical trial data- Developed, managed and tracked trial budget- Developed clinical outsourcing specifications to facilitate the selection of external service providers. Managed external service providers throughout the clinical trial- Led the development of program specific standards , ensured consistency and information exchange across studies and departments- Participated in on-boarding, mentoring and training of new colleagues- Implemented best practices for trial management and shared lessons learned- Represented Translational Clinical Oncology Clinical Operations on initiatives, served as Subject Matter Expert

Study management and monitoring: - Planned, organized and supported of clinical studies- Authored study protocols, informed consent forms and clinical study reports, designed case report forms- Conducted investigator meetings- Performed ethic committee submissions- Conducted monitoring visits- Supported investigational sites- Collaborated with external service providers- Reviewed and wrote SOPs