Job Description

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that concentrates on the discovery, development and commercialization of prescription medicines addressing some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Introduction to role:

Ready to turn complex regulations into a clear path that gets promising therapies to patients sooner? As a Start-Up Manager, you will lead country-level start-up activities that transform scientific ambition into operational reality, acquiring necessary government and ethical clearances with precision and pace. You will l join a team that blends scientific rigor with digital tools and data to accelerate, you will work closely with Clinical Research Associates, on-site Study Groups, and national management to streamline submissions, activate sites, and critical breakthroughs. Can you see yourself orchestrating approvals across multiple sites and authorities while keeping quality uncompromised?

Accountabilities:

• Country-Level Start-Up Leadership: Coordinate all start-up operations at the country level to agreed timelines, driving site activation and study readiness.

• Coordinate the collection, preparation, review, and tracking of application documents. Submit to Regulatory Authorities and IEC/IRBs as needed. Manage interactions and maintain subject matter expertise.

• Site Documentation Management: Prepare, review, and handle essential site documents to ensure completeness, accuracy, and compliance throughout start-up.

• Systems and Data Integrity: Update CTMS and other systems with site data in a timely manner; maintain and report on start-up performance metrics to advise decisions. eTMF

• Quality and Readiness: Collect and upload essential documents into the eTMF in line with ICH-GCP and internal SOPs; support quality checks to confirm site readiness for enrolment.

• Issue Resolution and Follow-up: Proactively follow up on outstanding submission actions with study sites; remove bottlenecks to protect timelines and achievements.

• Cross-functional Collaboration: Partner with CRAs, Local Study Teams, and the Local Study Associate Director; actively contribute in team forums to align plans and risks. Progress Reporting: Provide regular, transparent updates to country leadership on progress, achievements, and issues; bring up risks with clear mitigation plans.

• Ongoing Submissions Stewardship: Remain accountable for proper, timely submissions to ethics committees and regulatory bodies throughout start-up and the study duration.

• Continuous Improvement and Initiatives: Support Site Management & Monitoring initiatives within neighborhood, zonal, or international contexts; contribute country insights to improve processes and outcomes. Compliance and Standards: Champion adherence to ICH-GCP, local regulations, and AstraZeneca procedures; ensure inspection readiness at all times.

Essential Skills/Experience:

• Experience conducting study start-up activities at country and site levels, focused on regulatory and ethics submissions.

• Strong knowledge of ICH-GCP and relevant local regulations governing clinical studies. Hands-on experience preparing, submitting, and tracking applications for Regulatory Authorities and IEC/IRBs. Proficiency in handling essential documents and overseeing fundamental start-up progress data.

• Practical experience updating CTMS and handling eTMF content during start-up. Proven track record to collaborate with CRAs, Local Study Teams, and country leadership to meet start-up timelines. Ability to provide clear progress updates, manage issues, and drive timely resolution.

• Established expertise in the regulatory field related to clinical studies.

Desirable Skills/Experience:

• Experience supporting site supervision and tracking activities across local, regional, or global programs. Background working across multiple therapeutic areas or complex protocols.

• Track record of improving start-up cycle times through process simplification or data-driven insight. Comfort operating amid uncertainties and changing requirements while maintaining compliance and quality.

• Ability to analyze start-up data and translate insights into actions for stakeholders.

Why AstraZeneca?

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So,what’snext?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new insights and fresh thinking to the table? Dedicated! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Discover AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Connect with AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

17-Jun-2026

Closing Date

19-Jun-2026

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.