Study Start-Up Associate

Do you have expertise in Medical Affairs and a passion to accelerate innovative science? Would you like to apply your expertise to impact multiple internal and external stakeholders that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

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

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.

BUSINESS AREA In Medical Affairs, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We translate the wealth of medical and scientific expertise to ensure the data and materials we produce helps physicians to better treat patients at every point in the journey.

Come and be part of a talented, cross-functional team working together to improve lives and make the biggest possible impact for patients, science and society.

What you’ll do Accountable for study start-up and the maintenance of regulatory and ethics committee (EC) submissions, overseeing the collection, preparation, review, and tracking of documents required for the application process. Where applicable, responsible for submitting the appropriate applications and documentation to Regulatory Authorities and/or IEC/IRB during the start-up period, liaising with regulatory bodies and ethics committees and ensuring expertise in the regulatory field. Actively participate in Local Study Team (LST) meetings. In some countries, these activities may be performed by the regulatory department. Ensure timely updating of Clinical Trial Management System (CTMS) and other relevant systems with study site data during the start-up or application period, as required. Follow-up on outstanding actions related to submission with study sites during start-up, ensuring timely resolution. Ensure the timely collection and upload of essential documents into the eTMF in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements relating to submissions. Supports quality control checks performed by LSAD or delegate to verify that all country and site level trial essential documents required by ICH-GCP are collected and correct prior to site readiness for enrolment, in accordance with AstraZeneca SOPs. Provide regular updates to LSAD or Line Managers at the country level regarding study progress, planned milestones, and key issues throughout the start-up period. Support Site Management & Monitoring (SMM) in various initiatives at local, regional, or global levels, as agreed with SMM Line Management. Additional responsibilities may be assigned depending on local decisions. Remain accountable for the ongoing, proper submission of application documents to IEC/IRB and Regulatory Authorities throughout the start-up period and study duration.

Essential for the role Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders. Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: drug development process, international guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including site selection/set-up. IMP Development & Regulation – study vendor and biosample oversight Clinical Study Operations & Quality Management – study site selection and set-up Project Management – planning, prioritization, and delivering results with measurable impact Demonstrates personal effectiveness, self-accountability, and learning agility. Competence in financial, technological, and process management aspects of study operations. Business-level fluency in written and spoken English with strong active listening skills. Acts with integrity, ethical standards, and cultural awareness in all interactions. Collaborative team player in both in-person and virtual settings, with the ability to influence, communicate, and impact site interactions. Strategic thinker with effective risk-based decision-making, problem-solving, and critical thinking skills. Identifies opportunities to improve efficiency, optimize cost and time, and deliver high-quality clinical trials. Ability to travel nationally and internationally as required; valid driving license if applicable.

This role will be hired on a

contract-basis under 3rd party vendor

(extendable subject to performance review and business needs).

Why AstraZeneca? Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. If you’re curious to know more then please reach out to Aziza Fitriani. We welcome your application.

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