Local Study Manager

Do you have experience of, and passion for Development Operations? Would you like to apply your expertise to impact Clinical Studies in a company that follows the science and turns ideas into life changing medicines? Welcome to join our journey!

We are recruiting a Local Study Manager (LSM) to join our Nordic Site Management & Monitoring (SMM) team. Our main focus is to deliver clinical studies in close collaboration with partners in health care and academic medical institutions.

In this position you will be responsible for leading and optimizing the Local Study Team(s) (LSTs) at Nordic level to deliver committed components of global clinical studies. Our team is working across boarders in all four nordic countries. We prefer that you will have base in either the Stockholm or Copenhagen area and ability to travel nationally and internationally when required.

What you'll do

In this role, you'll have the opportunity to lead all aspects of the full site setup - from identification of sites, through qualification, initiation, monitoring, close and finally documentation archived.

We'll also rely on you to perform occasional site monitoring to support the flexible capacity model as well as being overall responsible for the study commitments within the Nordic countries and for timely delivery of data to required quality.

Furthermore, you'll ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality. This includes assuring timely submission of application and documents to EC/IRB at start up and throughout the study. We also expect you to prepare country financial Study Management Agreement and maintain accurate study budget in our financial system. Accountabilities include:

* Ensure all country and site level trial essential documents required by ICH-GCP
* Plan and coordinate applicable local drug activities - from local purchase or reimbursement to drug destruction
* Report study progress and updates to the Global Study Leader, Global Study Team and SMM Lead
* Develop, maintain and review risk management plan on country study level by proactively managing sites, partners, local and global vendors and customers to ensure risks are timely identified, mitigated and handled.

Essential for the role

We believe that you have a Bachelor degree or equivalent qualification in Life Science or other relevant field. This is complemented by proven experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies) and as Local Study Leader.

* Very good knowledge of international guidelines ICH-GCP as well as relevant local regulations
* Proven track record of leading empowering cross-functional teams to deliver clinical studies according to time plan, budget and with required quality
* Excellent understanding of the Clinical Study Process, including monitoring, as well as the Study Drug Handling Process and the Data Management Process

As we work in global cross-functional teams, you need to have excellent interpersonal skills - enabling effective collaborations with geographically dispersed colleagues. You need to be able to work independently, analytically and take initiatives. You also possess the ability to prioritize and balance multiple tasks. Furthermore, you have shown project management and organizational skills, as well as team building skills with the ability to mentor and coach.

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. Our SMM team is on a constant journey. We want to re-invent our organisation to find new and more effective ways of working in delivering our studies. We want each function to be accountable of their work and processes and every person counts. If you see opportunities in change and get motivated by trying new ways, this is the place for you!

So, what's next!

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

For more information about the position please contact hiring manager Heidi Egsgaard Frandsen (Heidi.Frandsen@astrazeneca.com).

We welcome your application, no later than February 28, 2022.

Where can I find out more?

Our Company https://www.astrazeneca.com/our-company.html

What Science can do https://www.youtube.com/watch?v=pmFx_jr2eFo

Inclusion & diversity at AstraZeneca https://www.astrazeneca.com/sustainability/ethics-and-transparency/inclusion-and-diversity.html