We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Join a talented global team that’s powering AstraZeneca to better serve patients, every day.

We are looking for you to come and join our Site Management & Monitoring (SMM) Nordic team in Denmark in the permanent role as Study Start Up Specialist.

SMM Nordic is part of the Development Operations in the Research & Development (R&D) function. SMM executes and delivers Clinical studies. Nordics contributes with a substantial part of the SMM Nordic delivery. Clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions.

What you’ll do
At AstraZeneca you will make a difference to patient lives every day. In this role, by being responsible for the delivery of the studies at allocated centers locally. As Study Start Up Specialist, you are a pivotal part of the Nordic Study Team and report center progress to the Nordic LSM. You’ll have a close collaboration with the Nordic Local Study Manager (LSM), local CRAs and Clinical Study Administrator (CSA) to ensure quality and quantity commitments delivered in a timely and efficient manner.

You are the local country contact and will get the opportunity to support as LSM from time to time, including proactively identify and facilitate resolution at local level of complex study problems and issues. We will also rely on you to mentor an coach more junior colleagues in the team.

Typical tasks:

• Prepare, write and compile the submission package to the ECs in our Nordic countries.

• Create and author the local ICFs based on the master ICF global template to ensure the ICF fulfills local requirements. 

• Prepare, initiate, monitor and close for an agreed number of centers and patients in clinical studies (phase I-IV) according to AZ Procedural Documents, international guidelines such as ICH-GCP and relevant local regulations

• Secure, perform and follow-up of local subject recruitment strategy and provide in-put to the Nordic recruitment strategy

• Negotiate and execute Financial Agreements with relevant staff at the investigational site (i.e. investigator, pharmacy, and laboratory)

• Contribute to the selection of potential Principal Investigators considering capability, competence etc., of the center

• Plan and lead national Investigator meetings as applicable

• Ensure local completeness of Study Master File documentation

• Plan and lead activities associated with local audits and regulatory inspections in liaison with CQA, CQM and LSM

Essential for the role

You have a university degree in biological science, healthcare-related field or equivalent by experience. This is complemented with at least 5 years’ of experience in the role as CSA with a very good knowledge of the clinical study and drug development processes, including risked based monitoring.

You also have:

• Good understanding of the clinical dataflow: good knowledge of the local and Nordic Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines

• Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

• Good analytical and problem-solving skills: seeing change as an opportunity to improve performance and add value to the business

• Very good knowledge of the clinical study and drug development processes, including risked based monitoring.

• Experience and knowledge about the therapeutic areas within R&I and CVRM.

We also believe that the you possess great computer skills and a good understanding of required IT system. Good language skills in Scandinavian and English, both verbal and written and ability to periods of extensive travel nationally and occasionally international travel. You also need to have a driving license.

Good communication skills are important, and we hope you are a person who enjoys teamwork and working in a collaboration environment.
 

Why AstraZeneca

There are many opportunities to develop yourself and your career. From our diverse portfolio and teamwork to our ground-breaking innovations – it’s a place for lifelong learning.

So, what’s next!

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

If you are ready to make a difference for patients around the world, join us! We welcome your application, no later than June 13th

Where can I find out more?

LinkedIn https://www.linkedin.com/company/1603/

Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

Closing Date

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.