The Specialist, Global Clinical Solutions (IRT Lead) provides global centralized services across drug projects and related activities, helping clinical development programs meet time, cost, and quality expectations across all delivery models.

Key Responsibilities

• Deliver GCS services that support clinical development activities across multiple projects and stakeholders.
• Set up and maintain systems, tools, and data associated with projects, services, and technology in partnership with Study Teams and external partners, ensuring appropriate standards, completeness, quality, and consistency.
• Support life cycle management and business continuity for operational processes, procedures, systems, tools, standards, procedural documentation, and training materials.
• Provide support to user communities by conducting relevant process, system, and tool trainings, facilitating knowledge sharing, establishing best practice, and maintaining effective communication with stakeholders across GCS and AstraZeneca.
• Perform analyses of processes and tools to define business usage and identify opportunities to improve efficiency and effectiveness of systems, methods, and processes; support the development of User Requirement Specifications and User Acceptance Tests.
• Contribute to business cases for continuous improvement projects that enhance how we deliver clinical studies.
• Prioritize workload effectively to achieve personal and work unit targets in a dynamic environment.
• Participate in change initiatives that evolve our ways of working and enable better outcomes for patients.

Essential Skills and Experience

• Bachelor's degree with 0+ years of work experience in the pharmaceutical industry or in clinical study delivery/clinical development processes.
• Proven organizational and analytical skills, as well as proven ability to multitask.
• Strong time management skills and task-oriented performance.
• Previous administrative training/experience.
• Computer proficiency.
• Excellent knowledge of spoken and written English.
• Strong communication skills.

Desirable Skills and Experience

• A good understanding of the clinical study process.
• Programming experience or programming aptitude.
• Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP.
• Shown willingness and ability to train others on study support processes and procedures.
• Demonstrate the ability to proactively identify risks and issues as well as possible solutions.
• GxP trained.

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The role reports to the Director of Clinical Operations, Dennis McHugh. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.

Responsibilities:

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.
• Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.

Requirements:

• Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent.
• 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience.
• General knowledge of regulatory requirements & GCP.
• Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks.
• Strong interpersonal, collaborative, and time management abilities.
• Excellent organizational skills; accurate and detail-oriented.
• High proficiency in Veeva Vault and Medrio.
• Strong spoken and written communication skills.

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