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Accountabilities

• Hold overall accountability for meeting country-level study commitments, ensuring timely delivery of high-quality data.
• Lead Local Study Teams for assigned studies, including CRAs, CSAs and other contributors, promoting collaboration, clarity of roles and strong performance.
• Drive optimal performance and compliance of Local Study Teams with AstraZeneca Procedural Documents, ICH-GCP requirements and local regulations.
• Oversee high-quality clinical and operational feasibility assessments for potential studies, providing robust input into study selection and design.
• Coordinate and manage the site selection process, including identification of potential sites and investigators, initial site quality risk assessments and, where needed, Site Qualification Visits to assess suitability and quality risk.
• Ensure timely submission of applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, support delivery of submissions to Regulatory Authorities in line with local requirements.
• Prepare accurate country-level financial agreements and maintain current study budgets within the clinical financial system, working closely with Director SMM or Director Country Head and Clinical Finance as appropriate.
• Ensure effective set-up and ongoing management of studies within CTMS, eTMF, study finance systems and any other tools or local platforms required by country-specific laws and processes.
• Oversee, manage and coordinate all monitoring activities from site activation to closure according to Monitoring Plans, reviewing monitoring visit reports and providing guidance and support to monitors.
• Conduct co-monitoring visits, accompanied site visits and training visits with study CRAs to drive quality, consistency and development.
• Proactively identify risks, facilitate rapid resolution of complex study issues and escalate when necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings that enable transparent communication, issue resolution and aligned decision-making.
• Build and maintain strong working relationships with Local Study Team members, site staff and global stakeholders to support smooth study execution.
• Report study progress, milestones, risks and mitigation plans to the Global Study Associate Director, Global Study Team and SMM/Study Operations Lead as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment targets.
• Develop, maintain and review a study-level country risk management plan, managing sites, stakeholders, vendors and customers to ensure timely risk identification and mitigation.
• Coordinate closely with National Coordinating Investigator or National Lead Investigator on recruitment and other key study matters where applicable.
• Plan and lead National Investigator Meetings in line with local codes when required.
• Support forecasting for study timelines, resource needs, recruitment, budgeting, materials and investigational product supply.
• Ensure set-up, updating and access to business-critical systems for Safety Reporting, Regulatory Submissions and Clinical Trial Transparency at country level.
• Ensure accuracy and compliance of all study payments in accordance with local regulations and agreements.
• Participate in training and coaching of new Local Study Team members to ensure quality delivery and adherence to ICH-GCP and AstraZeneca procedures.
• Maintain the study eTMF in an inspection-ready state at all times, ensuring documentation is complete, accurate and current.
• Plan and lead audit and regulatory inspection activities in collaboration with the Clinical Quality Associate Director and Quality Assurance teams.
• Contribute insights to process development and continuous improvement initiatives across the organization.
• Keep line managers regularly informed about study status, milestones, key issues and team performance.
• Ensure full compliance with local policies, codes of ethics and business practices in all study-related activities.
• Provide feedback on research trends, competing studies and site/investigator insights that can inform local strategy.
• Collaborate with the local Medical Affairs team as needed to support optimal study delivery and scientific quality.
• Actively support SMM initiatives at local, regional or global level as agreed with line management.

Essential Skills/Experience

• Bachelor’s degree in related discipline with 5+ years of previous experience in the pharmaceutical industry
• Relevant knowledge and ability to fulfill key responsibilities, including but not limited to:

+ Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management. + Personal Effectiveness & Drives Accountability in Others + Learning Agility + Financial, Technology & Process Competency + Active Listening, Fluency in written & spoken business-level English + Act with Integrity & high ethical standards + Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness + Identify and champion more efficient delivery of quality clinical trials with optimized cost and time + Ability to travel nationally/internationally as required + Valid driving license, if country employment requirement + Communication & Teamwork – Influencing, Collaboration, Impactful Site conversations + Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, + Decision Making, Effective Issue Management + Clinical Study Operations (GCP) & Quality Management – RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up + Deliver Priorities Results & Impact – Project Management, Recruitment/Retention Planning & Action

Desirable Skills/Experience

• Bachelor's degree in the life sciences field is preferred
• Previous experience in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies) is a plus

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Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits, as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).

Driving performance at the sites by proactively identifying and ensuring timely resolution to study-related issues and escalating them as appropriate.

Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.

Developing recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Documenting recruitment barriers and implementing mitigation plans.

Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.).

Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with Alexion SOPs.

Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements. Supporting/participating in regular QC checks of the eTMF.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review, and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.

Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed.

Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to Global Study team, Local study team, Country Operations Line Management, and/or Quality Group, representatives as required.

Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group.

Required qualifications include:

Minimum of 1 year of CRA monitoring experience

Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP

Excellent knowledge of relevant local regulations

Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas

Good understanding of the drug development process

Excellent understanding of Clinical Study Management, including monitoring, study drug handling, and data management

Excellent attention to details

Excellent written and verbal communication skills

Excellent collaboration and interpersonal skills

Good negotiation skills

Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

Valid driving license (dependent on country requirements)

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Responsibilities:

• Lead a high-performing team of Portfolio Data Engineers, fostering a culture of collaboration, innovation, and continuous improvement.
• Strategically prioritize and manage team workloads, ensuring effective task allocation and resource capacity to support team goals.
• Provide expert technical guidance and mentorship, ensuring adherence to best practices, coding standards, and architectural guidelines.
• Act as the Chief Data Technical Anchor for the PLMA domain, resolving critical incidents through Root Cause Analysis (RCA) and implementing permanent, resilient architectural fixes.
• Oversee the design, development, maintenance, scalability, reliability, and performance of data platform pipelines, aligning them with business needs and strategic objectives.
• Contribute to the long-term strategic direction of the Data Platform by proactively identifying opportunities for best practice adoption and standardization.
• Champion data quality, governance, and security standards, ensuring compliance and safeguarding sensitive data assets.
• Enhance efficiency and reduce redundancy by consolidating common tasks across teams.
• Effectively communicate decisions to stakeholders, building strong relationships and ensuring alignment on data initiatives.
• Maintain awareness of industry trends and emerging technologies to inform technical decisions.
• Lead the implementation of customer requests into data assets, ensuring optimized design and code development.
• Guide the team in delivering scalable, robust data solutions and contribute hands-on to critical projects, including design and code reviews.
• Lead technical decisions that drive data innovation and resilience.
• Demonstrate full stack cloud data engineering expertise, covering automation, versioning, ingestion, integration, transformation, optimization, and data modeling.
• Engage in agile planning, including scope, work breakdown structure, as well as roadblock resolution.
• Design solutions for cost and consumption optimization, scalability, and performance.
• Collaborate with Data Architecture and stakeholders on solution design, data consolidation, retention, purpose of use, compliance, and audit requirements.
• Drive engineering excellence by establishing and monitoring SWE-centric quality metrics (including DORA metrics and P99 latency targets).

Requirements:

• Bachelor's degree in Computer Science, Information Technology, Information Systems, Data Analytics, or a related field.
• 8+ years of experience in complex data environments, demonstrating increased responsibilities and achievements with:

+ Expertise in programming languages such as Python or Scala, and strong SQL skills. + Experience with ETL/ELT processes, data warehousing, and data modeling. + Experience with CI/CD pipelines, Docker, Git/Gerrit, and experience designing resilient deployment strategies and sophisticated release management. + Familiarity of data governance, privacy, quality, and monitoring.

• Proven experience in implementing sophisticated testing strategies, driving quality tool adoption, establishing comprehensive code review processes, and setting observability standards with advanced monitoring and proactive alerting.
• 5+ years of experience within the automotive industry or related product development environments and product lifecycle management.
• 5+ years of experience in leading software or data engineering teams, with a focus on team development and project success.
• 5+ years of experience in Big Data environments or expertise with Big Data tools, including:

+ Data processing frameworks and data modeling. + In-depth knowledge and practical experience with Google Cloud Platform services. + Proven experience in monitoring and optimizing costs and compute resources in hyperscaler platforms.

• Significant experience leveraging Generative AI and LLMs to optimize data engineering workflows (e.g., automated code generation, documentation, or metadata management).

Preferred Qualifications:

• Master's degree in Computer Science, Engineering, or a related field.
• Expertise in GCP based data engineering services like BQ, Dataflow, Airflow, Dataform, Datastream, Apache Beam, Cloud Run, Cloud Functions
• Familiarity with automotive Product Development processes, including program planning, design validation, and cross-functional collaboration across engineering, manufacturing, and supplier teams to deliver data-driven insights at each lifecycle stage
• Experience in managing and scaling serverless applications and clusters, focusing on resource optimization and robust monitoring and logging strategies.
• Proficiency in unstructured data ingestion, including experience with data modeling and preparation techniques to support AI and machine learning workloads.
• Experience with AI architecture and AI enabling tech (graph database, vector database, etc)
• Familiarity with data visualization tools (e.g., Power BI, Tableau).
• Working knowledge of ontology, semantic modeling, and related technologies

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