Global Study Associate
Due to an increase of new compounds and new studies we are looking for a Global Study Associate to join our Haematology Clinical Operations team in Oss. In this role you will be responsible for early phase (I&II) Haematology studies. You will administer and coordinate our international studies ensuring a smooth and effective running.
This great opportunity also allows you to work with our AstraZeneca study teams in the UK, Canada and the US. As well as with your Clinical Operations colleagues from Acerta Pharma, whilst contributing to the quality of life of Haematology patients. Whilst in this role you will get the opportunity to learn, develop and potentially grow into the position of Global Study Manager.
Acerta Pharma is a member of the AstraZeneca Group and together we work on our combined Haematology pipeline compounds. Because of this intense collaboration with AstraZeneca, Acerta Clinical Operations plays a significant role in drug development in Haematology. As part of the significant expansion in the Netherlands, we are in the process of building a new research centre in Pivot Park with room for more than 140 colleagues.
Global Study Associate
Oss, The Netherlands
Full-time (32-36 hours negotiable)
Hybrid working (3 days per week office based)
As a Global Study Associate you have a key role within the project teams. You will coordinate and organise all administrative and logistical aspects of the study. You are constantly in contact with various stakeholders ensuring all processes are followed accordingly and within the set timelines. Your duties include setting up, conducting and closing studies, and actively contribute to possible process adjustments and improvements. You are flexible, easy going and we strongly believe in team work to deliver the best results together.
In addition you will be:
• Initiating and leading the set-up of the electronic Trial Master File (eTMF). As well as maintaining and closing the eTMF, ensuring compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AstraZeneca SOPs.
• Coordinating regular Quality Checks (QC) and reviews of the TMF, ensuring continual inspection readiness.
• Coordinating study related activities and preparing study documents, according to the applicable guidelines, SOPs and ICH-GCP.
• Tracking the progress of clinical trials, including patient recruitment, trial supplies and trial documentation according to applicable quality standards.
• Coordinating documents of suppliers (e.g. Clinical Research Organisations (CRO’s)) and monitor the approvals of site and supplier contracts.
• Generating purchase orders, process invoices and make sure that expenses remain within the approved budget.
What do you bring?
• Bachelor or Master in (Bio)Medical Sciences, Chemistry, Pharmacology, Life Sciences or related study.
• At least 1 year relevant working experience with logistical and administrative guidance of clinical trials.
• At least 1 year experience working at a CRO, Academic Hospital or other pharmaceutical company.
• Experience with ICH-GCP guidelines.
• Experience with eTMF.
• Strong communication skills in English (both written and verbally).
• Competencies: organized, accurate, proactive, able to keep good overview, prioritise and work independently.
• It is important that you are already living (or due to move) within easy travel distance to our offices in Oss. You will be required to work from our offices 3 days per week.
What do we offer you?
• Future growth opportunities within Acerta Pharma & AstraZeneca into the role of Global Study Manager. There are also international growth opportunities. • The opportunity to work together in a large, committed, experienced and international team, where you can learn all about the development of Haematology drugs.
• Excellent working atmosphere: a high professional team with great team spirit: meaning, play to win, helping each other where you can and room for fun things besides work (monthly drinks, joint lunches, outings with the team).
• Good salary and secondary benefits including 8% holiday allowance, 25 holidays on a full-time basis. Additional: office closure between X-mas and New Year + Good Friday. Collective pension with a fixed percentage personal contribution, bonus scheme.
• Vitality of our colleagues is important to us, which is why you can exercise with discount or make use of our bicycle plan. You can partly work from home.
• Annual contract with the intention to convert this to a permanent contract after one year.
You will work in the Clinical Operations Team in Oss which consists of >25 experienced professionals in various roles. We work closely with AstraZeneca's Haematology Clinical Operations teams in UK, CAN and US. The culture in Oss is informal and ambitious, a great team spirit and a willingness to share and learn from each other. We all work for the same purpose: to develop drugs that make a difference in patients' quality of life. The team looks forward to welcoming new, energetic, experienced and inquisitive colleagues.
About Acerta Pharma
At our international headquarters at the Pivot Park in Oss, the Netherlands, we are working to develop new treatment options for patients with specific types of blood cancer. Together with our colleagues of AstraZeneca in the US, Canada and UK we are committed to innovative drug discovery and development, especially in the field of haematological oncology. Acerta Pharma has received approval from both the US (FDA) and the European Regulator (EMA) for its small molecule BTK inhibitor for treatment of patients with chronic lymphocytic leukemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines to treat haematological malignant diseases.
Our future depends on healthy people, a healthy society and a healthy planet. We believe that these elements are interconnected, and that together we must build a sustainable future.
We follow the science, always put patients first and we do the right thing. Moreover, we encourage entrepreneurship and we play to win. These core values guide us. At Acerta Pharma we believe in the power of diversity. Working in diverse teams is important for our joint creativity and innovative strength. Listening to and learning from each other also ensures that everyone's talent is used to the full. We encourage colleagues to learn and grow every day to maximize their talent and opportunities.
We offer an exciting, dynamic work environment, from 2024 in a brand new, high end laboratory at our very own Pivot Park.
If you are interested and would like to apply we would like to receive your cover letter and CV.
You can upload your CV and cover letter at the bottom of the second page.
If you have any questions about this vacancy, our Recruitment Team, Caroline van Oppen, Karin Raadschelders and Maaike Willems can be reached at firstname.lastname@example.org or by phone on +31(0)85 - 047 0244.
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.