Make a more meaningful impact to patients’ lives around the globe
Here you’ll have the opportunity to support us in our work to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases.
Internship: 1 or 2 semesters
Student location: AstraZeneca, Gothenburg, Sweden
Start: January 2022
We are offering an internship as Global Study Associate who will join our BioPharmaceuticals R&D Study Management Early team. The position will be based on our vibrant R&D site in Gothenburg, Sweden. Here you will be given an opportunity to gain attractive work-life experience from the pharma industry in a global environment. You will get insights in clinical development at the same time as you develop your administrative and project management skills.
BioPharmaceuticals Study Management Early, are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within Cardiovascular Renal Metabolism (CVRM), Respiratory & Immunology (R&I) and Infectious Diseases. We have staff across the globe, in Sweden, UK and US.
During your internship you will join the team of Global Study Associates. A Global Study Associate joins a global study team and performs coordinating activities that ensure quality and consistency and contributes to delivery of global clinical trials through providing administrative support. As a Global Study Administrator you may work across several clinical studies. The exact accountabilities will differ depending on the exact nature of the clinical programme so you'll need a high degree of flexibility and an ability to coordinate multiple tasks.
Your responsibilites may include:
- Support the Global Study team members by completing delegated study work as required. You may work across many different studies and delivery models concurrently.
- Oversee the collection, review and track relevant study documents in the TMF.
- Set-up, maintain and close of the Trial Master File (TMF). Ensure compliance to ICH-GCP and AZ SOPs. Focus may be on closing and archiving activities of aged studies.
- Interact/collaborate with internal and external stakeholders in collection of regulatory and other essential documents/information.
- Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
- Contribute to and distribute meeting material and other varied forms of communication.
- Contribute to electronic applications/submissions by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities.
- Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.
- Coordinate tasks during the study process, audits and regulatory inspections.
- Administrative knowledge and interest in the clinical development of life-changing medicines
- Proven organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
- Ability to prioritize appropriately and to be adaptable
- Computer proficiency in day-to-day tasks
- Excellent verbal and written communication in English
- Demonstrate ability to work independently, as well as in a team environment
- Administrative experience
- Experience within the pharmaceutical industry
- Basic understanding of the drug development process and/or experience in supporting clinical trials and study development
- Basic knowledge of ICH-GCP principles and relevant regulatory requirements
- Experience from working in Veeva Vault
Randstad Life Sciences is cooperating with AstraZeneca in this recruitment process. We only handle applications sent through Randstad’s website.
All chosen candidates need to pass a background check and an alcohol and drug test before starting the project. Deadline for application: 2021-11-14
For more information: Veronika Knudsen email@example.com
or Kerstin Karlsson firstname.lastname@example.org
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures collaboration, openness and innovation. Therefore, we have created space for meetings, socializing and relaxation, where spontaneous meetings can give birth to new innovations. The unexpected ideas or thoughts that can come from a chat over something as simple as a cup of coffee or a stroll on our “walk and talk” meeting trail. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.