Study Start-Up Manager

AstraZeneca•Wilmington, DE

1d•Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Study Start-Up Manager The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics. The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

Requirements

Bachelor degree (preference for sciences) or equivalent experience
Minimum 2+ years’ experience with oncology startup
Minimum 2+ years’ experience with informed consent review
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
Basic understanding of drug development process
Excellent understanding of Clinical Study Management and study start-up
6+ months experience with Veeva Clinical Vault both as electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS)
Experience with Microsoft Teams, OneNote, Excel, Box.

Nice To Haves

Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

Responsibilities

Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
Accountable for review of informed consents from site level, coordinates additional review with internal stakeholders; facilitates return of comments/approvals to sites to action.
Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
Actively participates in Local Study Team (LST) meetings.
Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements.
Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.