• Represent Samus at clinical site initiation visits to ensure the site is adequately trained and meets appropriate requirements to conduct clinical research including adequate staff, facilities, equipment • Perform co-monitoring oversight• Vendor selection and management, including risk management, metrics, finance and reporting• Key systems oversight (DM, CTMS, Monitoring, Safety, Central Lab, Investigational Product)• Ensure clinical data is collected, managed and reported clearly, accurately and securely.• Develop key clinical study documents and study tools (e.g. protocol, CRFs, informed consent forms, monitoring plans)• Participate in internal safety and protocol compliance meetings and independent safety review meetings (e.g. Medical Monitor, Safety Review Meeting Committee and Cohort Management). • Ensure clinical development programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and specific country regulations.• Manage Phase 1 and 2 Oncology clinical program including performing protocol, clinical site management, study budget, and informed consent and review and approval, and oversight of clinical service providers (contract research organization, laboratory, and central imaging vendors)• Lead development of clinical processes (SOP and Work Instructions) for all phases of clinical trial conduct from initiation through close out• Serve as Data Management subject matter expert (SME) for product platform including performance of quality review and monitoring oversight at hospital sites via Electronic Medical Record (EMR) and Electronic Data Capture (EDC) databases

• Ensure timely, accurate, and on budget delivery of contracted services for three Oncology client relationships (approximate total value of $ 21 million)• Serve as primary point of escalation (client level and internal) for issue resolution• Act as functional/SME representative during regulatory agency inspections, including responding to interview questions and providing written responses to regulatory agency findings which may include provision of recommendations for corrective active procedures (CAPA)

Key responsibilities include personnel management of mid to senior level data management project leads and operational relationship management for preferred strategic service partner

Provided Data Management leadership and expertise to project and study teams to support drug development processes and global project submissions through to approval. Managed data management components of project and study budgets and vendor performance. Personnel management of junior to mid level lead data managers. Contributed to cross-functional groups in developing critical strategies in SOP process and standards development.

Led and partipcated in the development of departmental and inter-departmental SOPs, WI'sProvided Data Management leadership and expertise to project and study teams to support drug development processes and global project submissions through to approval. Personnel management of junior to mid level lead data managers and medical coding associate.

Act as Lead Data Manager for specialty products in Rare DiseaseOversee Data Management activities of external vendors and CROs

Act as Lead Data Manager for rare disease registry for Pompe disease including performance of data review, query generation, and SAE ReconciliationManaged activities of external service providersPerformed audit of data management vendors to ensure compliance with SOPs and Work Instructions