Study Start-Up Manager

Accountabilities for this role include:

• 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. • Other responsibilities applicable within country may be covered by an addendum to this job description.

Date Posted

08-Oct-2025

Closing Date

17-Oct-2025

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.

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 authorisation and employment eligibility verification requirements.