Local Study Associate Director Biopharma

Introduction to role

Are you ready to lead country‑level clinical study delivery that accelerates breakthrough medicines to patients? As Local Study Associate Director, you will turn complex operational challenges into precise execution that safeguards data quality, drives recruitment, and keeps studies inspection‑ready.

In this role, you will lead Local Study Teams across multiple sites, aligning seamlessly with the Global Study Team to deliver on country commitments with pace and rigor. You will be accountable for end‑to‑end study execution in country—feasibility, site selection, submissions, monitoring, data delivery, and close‑out—while ensuring full adherence to ICH‑GCP, local regulations, and AstraZeneca standards.

Do you thrive in a matrix environment where your decisions shape timelines, budget stewardship, and stakeholder confidence?

You will leverage clinical operations expertise, risk‑based thinking, and technology to remove barriers, anticipate issues, and enable high‑quality, on‑time delivery. Your leadership will connect investigators, monitors, and cross‑functional partners to the shared goal of generating robust evidence that can transform patient care.

Accountabilities

• Country Study Ownership: Hold overall responsibility for country‑level study commitments, timelines, and high‑quality data delivery aligned with the Global Study Team.
• Local Study Team Leadership: Lead CRAs, CSAs, and other contributors; set clear expectations, coach for performance, and cultivate a culture of accountability.
• Compliance and Quality Governance: Drive compliance with AstraZeneca procedures, ICH‑GCP, and local regulations; embed quality by design and inspection readiness from first site to last patient out.
• Feasibility and Site Strategy: Coordinate feasibility, site selection, qualification, and risk assessments to activate the right sites quickly and sustainably.
• Ethics/Regulatory Submissions: Ensure timely, complete submissions to Ethics Committees/IRBs and support Regulatory Authority submissions to protect study timelines.
• Budget and Systems Stewardship: Maintain study budgets; ensure accurate, timely data in CTMS, eTMF, and finance systems to enable transparent oversight and decisions.
• Monitoring Excellence: Oversee monitoring activities, review monitoring reports, and conduct co‑monitoring and training visits to uphold patient safety and data integrity.
• Risk and Issue Management: Identify risks early, resolve issues decisively, and elevate when needed; maintain the country risk management plan.
• Stakeholder Communication: Lead Local Study Team meetings and manage clear, consistent communication with investigators and internal stakeholders.
• Recruitment Acceleration: Support country recruitment strategies and investigator engagement to achieve enrollment and retention targets.
• Audit and Inspection Readiness: Lead readiness activities and ensure actionable follow‑up on findings to maintain a constant state of preparedness.
• Capability Building and Improvement: Participate in coaching and training of team members; champion continuous improvement and SMM initiatives that raise performance across studies.

Essential Skills and Experience

• At least 2 years of current experience in the same role role
• Bachelor’s degree in a related discipline (preferably life sciences) or equivalent qualification. Previous pharmaceutical industry experience, preferably in Clinical Operations (CRA, SrCRA) or related fields.

Relevant Knowledge

Drug development process, GxP processes, ICH‑GCP, country regulations, AZ therapeutic area knowledge, clinical study management, project management, monitoring, study drug handling and data management.

Role‑Required Skills

• Personal Effectiveness & Drives Accountability in Others
• Learning Agility
• Financial, Technology & Process Competency
• Active Listening and business‑level English
• Act with Integrity and high ethical standards
• Team leadership across virtual and in‑person environments
• Communication & Teamwork
• Effective risk‑based thinking
• Clinical Study Operations (GCP) & Quality Management
• Project Management and Recruitment/Retention Planning

Desirable Skills and Experience

• Advanced degree in life sciences or a related field.
• Demonstrated leadership of country‑level delivery across multiple complex interventional studies.
• Proficiency with CTMS, eTMF, and finance systems; experience building operational dashboards for study oversight.
• Strong record of audit/inspection readiness and managing CAPAs to closure.
• Hands‑on experience with risk‑based monitoring approaches and quality by design.
• Proven ability to design and optimise recruitment/retention strategies using data and site insights.
• Vendor oversight and contract/budget negotiation experience.
• Fluency in local language(s) in addition to English.
• Experience coaching and developing CRAs/CSAs and leading change in process improvements.
• Established relationships with academic networks, research hospitals, and key investigators.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.