• Lead a group of Clinical Data Management (CDM) Specialists with the goal to successfully support clinical development in harmony with company standards, GCP and FDA quality standards and regulations in the area of clinical data management.• Provides coaching, mentoring and performance management to direct reports in their career development.• Contribute to department capacity planning, prioritization and resource allocation. • Plan trial and project budgets for CDM• Develop the strategic goals and directions for the department.• Develop networks within and outside the company.• Project manager of international, outsourced projects and trials.• Project manager expertise in mega-trials.• Regulatory inspection expert who works with other TDM preparing for regulatory inspections; including TDMAP review, hold mock inspections, provide guidance on CDM overview presentation template. I have participated in and supported other TDMs in inspections from the FDA, EMA, NPRA and CFDA.• Vendor Management expert who provides CRO oversight tools to data managers to ensure vendors are compliant with regulatory standards to produce a quality database.• Collaborate with Quality Management with non-compliance issues, CAPAs and internal audits to provide direction for process and procedures improvements within CDM.• Collaborate with the Risk Based Quality Management group to plan for capacity of Business Partners and Central Monitors who will support the trials setting up the Integrated Quality Risk Management Plan and their Trial Risk Assessment tool as well as support the Clinical Monitors during conduct. • Provide guidance and support to TDMs for CDASH and SDTM standards to be used for all trials and projects.

• Define, collect and analyze BDS metrics. • Active participation in the development of international processes in the area of BDS quality management, training and CRO oversight, including development, writing and implementation of policies.• Lead or participate in international working groups or projects • Timely development of new or updated standard processes• Steer the BDS submission project functions towards efficient project management throughout the global submission process.• Support inspection readiness for BDS trial and project teams• Guide project teams in all aspects that require submission management input.• Participate in governance committees with BDS vendors in order to streamline services and oversight. • Develop standard CRO oversight plans and guide team members of outsourced trials in their process. Support the development of oversight plans per trial and project to ensure the sponsor oversight is conducted in a homogeneous, efficient and effective way. • Support the development of Key Performance Indicator for CRO oversight.

trial data manager, set up trials including mega trials, review and comply with SOPs, guidelines, principles of GCP and FDA guidance(s), work with CROs or academic organizations, project data manager, input into core protocol, core CRFs, project database, works with PSTAT and PPROG, part of submission team, prepare and validates submission datasets and compliant with electronic submission guidelines, part of inspection readiness team, ensures documentation is complete and consistent, collaborates with other teams, supervise and manage CROs work and timelines.