April Bishay

Clinical operations leadership professional with more than 20 years of clinical research experience across CRO, biotechnology, and pharmaceutical organizations. Extensive experience leading Clinical Research Associates (CRAs), developing high-performing teams, and ensuring successful delivery of global clinical trials in compliance with ICH-GCP and regulatory requirements. Passionate about people leadership, combining high performance expectations with coaching, employee engagement, and continuous development.

Associate Director, Clinical Operations - Lin BioScience - Taipei, Taiwan

(2023-06)

Global Clinical Trial Manager responsible for the strategic planning, execution, and oversight of a global relapsed/refractory AML and ALL clinical study, ensuring delivery on time, within scope, and in compliance with regulatory requirements, company standards, and ICH-GCP guidelines. Regularly visits sites in Australia, USA and Taiwan to build relationships with the PI and site staff, training and oversight of CRO quality. In the absence of a Clinical Operations Manager, assumed key clinical operations leadership responsibilities, including departmental risk management, budget oversight, three-year budget forecasting, full line management responsibilities, clinical operations quality oversight, staff training, procedural development, and implementation of departmental structure.

Currently developing a CRA development program and leading training initiatives for junior staff to support their professional growth and prepare for future company expansion.

Sr CPM - Lin BioScience - Taipei, Taiwan

(2025-01 - 2026-06)

Associate Director, Clinical Research - AstraZeneca - Taipei, Taiwan

(2022-12 - 2023-12)

Responsible for line managing Clinical Research Associates (CRAs) and Local Study Associate Directors (LSADs), mentoring, coaching, training, planning and utilisation of staff resource, objective setting and performance follow-up. Also responsible for ensuring study sites are identified, site qualification performed, set up, initiated, monitored, closed and documentation archived, as agreed locally, and in compliance with AZ Procedural Documents, country regulations and international guidelines such as ICH-GCP. Managed multiple functional service provider relationships on a country level between AstraZeneca Site Management & Monitoring (SMM) group and resourcing requests.

Developed training materials for CRA training in support of CRA career development and onboarding. Performed co-monitoring visits for training and accompanied site visits to access quality of CRA work. Role ceased to exist due to company restructuring.

Associate Director, Clinical Quality & Compliance - AstraZeneca (formerly MedImmune) - Cambridge, UK

(2021-01 - 2022-12)

Responsible for supporting the delivery of Quality Management activities related to clinical development within R&D, working with stakeholders across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Development Operations and other Clinical R&D functions.

• Responsible for leading a cross functional team in the implementation of an internally developed program to support AZ clinical operations globally. Program brought information from various systems into one platform to support a more streamlined working environment and more efficient working practices.
• Supported internal and external customers with their quality issue investigation, root cause analysis and CAPA development. Also assisted with follow up activities to ensure issues have been adequately addressed and actions are effective.
• Learning Maintenance: Serve as a Business Learning Lead for Clinical Quality & Compliance in the maintenance/oversight of the learning curriculum. Also, maintain / oversee training requirements for CROs conducting studies under legacy MedImmune contracts.
• Periodically served as an audit coordinator working with QA and auditees across various AstraZeneca functions to support audit preparation activities, documentation requests and follow up of audit findings.
• Worked with a member in supplier outsourcing to develop a process for operational due diligence of clinical suppliers where a process and procedure had not existed previously. Also developed supporting documents for this process such as operational due diligence sign off and evaluation forms to show the documentation and decision-making process when performing operational due diligence of suppliers. Served on the Operational Due Diligence Governance Committee for several years before handing the
• Provided input on updates to AZ procedures, template documents, forms and manuals in alignment with updated regulations, internal processes, etc.
• Led change management and communication activities for the Study Quality Compliance tool to be introduced to study teams throughout AZ. This tool was developed to streamline audit preparation activities as well as helping various functions to oversee study compliance in real time to remain audit ready at all times.
• Worked on various workstreams in order to help with the integration of MedImmune into AZ as well as other acquired companies by reviewing and consolidating procedures and integration.

Sr. Manager - AstraZeneca (formerly MedImmune) - Cambridge, UK

(2013-01 - 2021-12)

Sr. Manager, Global Clinical Study Delivery - MedImmune - Cambridge, UK

(2012-01 - 2013-12)

Supported vision, leadership, mentoring and development for GCSD personnel in all therapeutic and geographic areas and across all study phases and responsibilities. Responsible for supporting the design, development, modification, and evaluation of the GCSD infrastructure to expedite the successful delivery of clinical trials. Provided functional line management support to Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) to achieve organisational study delivery goals and objectives to time, quality and budget expectations.

Drove standardization of processes and roles and responsibilities across GCSD personnel.

Clinical Operations Manager - PPD

Led teams of CRAs, Clinical Trial Assistants, and Research Assistants. Responsible for recruitment, onboarding, performance management, mentoring, workload allocation, and resource planning across more than 150 staff. Developed a one-year CRA training program, delivered operational training, conducted accompanied monitoring visits, and used audit trends to identify training opportunities that improved quality and performance across the organization.

B.A. - Biology with Concentration in Microbiology - College of Charleston

Master in Business Administration - Business Administration - University of Maryland University College