Kennett Square, Pennsylvania, United States
Specialties: Data management, operational oversight/leadership, vendor/investigational site management, clinical study budget management, clinical monitoring, protocol development/authoring, risk identification and mitigation, strong computer knowledge, powerful presentation skills
Medical Evidence Delivery Operations within the Oncology Business Unit (OBU) is responsible for the operational delivery of observational and interventional AstraZeneca sponsored studies, Externally Sponsored Scientific Research and Early Access Programs to generate the evidence to build confidence in AZ therapies and provide access to AstraZeneca therapies for patients in need. The Associate Director, ESR Global Operations Lead is responsible for portfolio level oversight on assigned tumor type area(s). This role will oversee performance of assigned ESR portfolio of studies to budget, quality, and timelines. The Associate Director, ESR Global Operations Lead is a single point of contact for all ESR operational aspects for assigned tumor type area(s). This role is responsible for supporting and providing direction on ESR operational processes within tumor type area including leading and/or facilitating resolution for ESR operational challenges.
AstraZeneca and MedImmune recognise the important role that Externally Sponsored Scientific Research can play in expanding the knowledge related to a company product and/or its associated disease area(s). This research can advance science and contribute to the development of better medicines for patients consistent with the company’s overall research and global development strategies. The External Scientific Research (ESR) Manager is responsible for the local management and co-ordination of Externally Sponsored Scientific Research Projects within the United States. This role will interface with US Medical Affairs and External Scientific Research Operations (ESRO) and external organizations (e.g. Principal Investigator(s) and/or Institutions) to ensure adherence to all relevant policies, processes and procedures.
• Leading all clinical study activities that ensure quality, consistency, and integration of study data and progress clinical deliverables to time, cost and quality from Study Concept through database lock and study close-out activities. This involves interfacing with data management teams to facilitate the delivery of study data, implementing globally agreed Clinical Development (CD) strategies,, contributing to protocol development and the development of other documents as appropriate, monitoring study conduct and progress, and proactively identifying and resolving, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives. Develop and maintain study budgets, timelines and study goals while being accountable for the delivery of the clinical study deliverables. • Consistently maintain interactions with key stakeholders including the facilitation of communications with MCs, Clinical Research Organizations (CROs), CPUs/Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities Recent Pharmaceutical Project Work: Phase I & II Emerging Oncology Phase III Oncology Phase III Neuroscience
• Perform PK/ADME experiments and biological sample analysis utilizing existing methods under section SOPs to generate study data • Organize data in tabulated and graphical summaries
• Perform assay validation, sample preparation and extraction and report data in accordance with GLPs and SOPs • Run multiple interrelated scientific studies simultaneously