Serve as SDTL
* Responsible for planning and leading the delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR).
* Form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality.
* Contributes to steering committees, submission assembly teams, regulatory defence teams, and contributes to Advisory Boards as necessary.
* Prepare and deliver study-level feasibility, develop recruitment strategies, and oversee the delivery of the approved Clinical Study Protocol.
* Work with Line Managers to identify resource needs and secure resources from various departments, forming a motivated and aligned study team.
* Forecast and manage study timelines, budgets, materials, and develop detailed study plans and feasibility assessments.
* Plan and lead audit activities in liaison with CA+A; contribute to regulatory inspection strategies as required.
* Participate in negotiations and the selection process of external service providers.
* Develop and manage contingency risk plans to ensure timely delivery within quality, budget, and schedule, escalating issues as appropriate.
* Lead preparation and delivery of study documents (e.g., Protocols/amendments, data management documents), ensuring operational inputs from relevant functions.
* Track and manage study timelines, budgets, and resources, ensuring updates in systems like IMPACT and ACCORD.
* Plan, lead, and ensure appropriate training at Investigator/monitor meetings.
* Coordinate and contribute to timely delivery of operational components of submissions to regulatory authorities (e.g., CSRs, annual reports).
* Ensure study-related decisions consider local management requirements and constraints, maintaining active communication within the study team.
* Drive best practices and staff development through mentoring, training, and performance feedback.
* Support project activities aligned with experience to ensure effective study delivery.
Serve as LSTL
* Overall responsibility for study commitments within the country, ensuring timely delivery of high-quality data as per SMA.
* Lead Local Study Team(s), including monitors and study administrators.
* Optimize the performance of local Study Team(s), ensuring compliance with AZ procedures, ICH-GCP, and local regulations.
* Develop Local Monitoring Plans based on Targeted Monitoring guidance.
* Review monitoring visit reports and advise monitors on study-related issues.
* Perform co-monitoring and QC visits as needed.
* Identify and resolve complex study problems proactively.
* Organize regular Local Study Team meetings.
* Foster good relationships within the team and with investigators.
* Report progress to the Study Leader/Team and contribute to recruitment strategies.
* Coordinate investigator selection, national meetings, and study timelines.
* Work closely with Study Drug Coordinators for drug planning.
* Ensure timely preparation and submission of country-specific study documents and applications.
* Maintain the Study Master File and ensure proper documentation and archiving.
* Participate in audits and inspections, contributing to process improvements.
* Provide updates to Line Managers on study milestones and monitor performance.
* Ensure compliance with local policies and codes of conduct.
Education, Qualifications, Skills, and Experience
* University degree and/or equivalent in biological sciences or healthcare-related field.
* Minimum 5 years of experience in Clinical Operations or related fields, with at least 1 year as LSTL.
* Excellent spoken and written English skills.
* Good IT system skills and adaptability.
AstraZeneca is an equal opportunity employer. We consider all qualified applicants without discrimination based on various protected characteristics.
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