• Lead and manage a multicultural team of up to 100 direct reports in a matrix organization with budgets responsibility.• Ensure high-quality operational execution of clinical trials phase I-IV, including resourcing, talent development, and performance evaluations.• Responsible for preparation and conduct of local and international inspection for studies and sponsor and follow-up. • Exemplify strong leadership skills, building trust and motivation within the team.• Pioneer regular knowledge transfer initiatives to ensure profound knowledge exchange and to enable efficient global clinical trial planning and execution.• Coach the team on strategic setup, team building, conflict resolution, and foster a feedback culture as well as providing networking opportunities.• Organize impactful team and department meetings, leveraging innovative ways of working with new tools.• Implementing EU-CTR and support studies teams in aligning with new regulations and contributing to different workstreams to improve efficiencies. Organizing of orientation center for potential staff for their development.• Local Responsible Person for IMPD Label approval• Active in German pharma association (vfa)

Functional Manager/ Line Manager for Study Manager, Global Project Manger, Study Lead Monitor and IxRS & Medication Manager in Berlin, Leverkusen, Canada, US and China• Lead and coach a global team in a matrix organization with budgets responsibility.• Successfully managed strategic planning, operationalization, and tracking of a highly complex Clinical Development Project, focusing on milestones, costs (Budget up to 5Mio €), quality, and risk management, in different therapeutic areas• Ensured accurate and accessible information flow to customers and stakeholders for effective communication and decision-making.• Fostered close collaboration across functions to keep the project on track and achieved meticulous tracking of study resources.

Functional Manager/ Line Manager for Study Manager and Global Project Manger in Berlin, Leverkusen, Canada, and the US.

• Oversaw complex global clinical studies within defined timelines, budgets (up to 3 Mio€), and quality standards for regulatory approvals.• Led cross-functional international teams of 10-30 team members, fostering clear structure and trust to meet commitments and deliver studies on time.• Collaborated with Drug Supply Management to manage intricate drug supply chains and ensure timely delivery to sites.• Responsible for audit & inspection preparation, support during audit/inspection conduct and follow up. • Coordinating with and contracting of CROs and trial service providers• Coordination and conduct of several international CRA and investigator meetings (with representatives from up to 20 countries)

Project Management in Clinical Research