Global Study Manager at AstraZeneca in Gothenburg

We are seeking a Global Study Manager to join AstraZeneca in Gothenburg!

Do you have experience in clinical study management and would like a role where your expertise, as well as your leadership skills, will be highly appreciated? Are you team oriented and do you, as we do, put patients first in your work to make a difference? Then AstraZeneca might be the right place for you to contribute and thrive.

We are recruiting for a Global Study Manager who will join the Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team – which forms part of BioPharmaceuticals Clinical Operations . The position will be based in the vibrant R&D sites in Gothenburg, Sweden

Purpose, Offer and Benefits

This is a 6 months consulting assignment. You will be employed by TNG during this time.

The selection process is ongoing.

At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity

Your Responsibilities

• To support the Study leader in project management as per agreed delegation.
• Lead the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents such as specifications, study specific procedures, contracts etc.
• Management of study vendors....
• To ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contribute to risk and issue identification, identification of critical to quality factors, development of mitigation and/or action plans for identified risks and issues.
• Adhere to AZ SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager.

In this position you will play a key role in the study team and work closely with the Global Study Leader to fulfil their accountabilities through coordinating activities that ensures quality, consistency and integration of study data.

The Bigger Picture

In the position as Global Study Manager you will support the delivery of global early clinical studies from study set-up through maintenance, close-out and study archiving. It is a role where you work cross-functionally with internal and external partners to lead and deliver aspects of the clinical study according to applicable trial regulations (ex ICH-GCP), AstraZeneca Standard Operating Procedures (SOPs), and in line with AstraZeneca´s policies and value.

Our Expectations

• Experience working within a global clinical study team and managing third party vendors.
• Experience working with country/regional study teams.
• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
• Experience from pharmaceutical industry and clinical trial experience.
• Good understanding of the drug development process, study management, drug handling and data management as well as deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
• Proven organizational, time management and analytical skills; demonstrate very high quality in English, both in written & verbal communication.