Global Study Associate

Clinical Operations in haematology is expanding! For phase I – III studies we are looking for a Global Study Associate for Acerta Pharma in The Netherlands, Oss.

As a Global Study Associate, you are the linking pin for international clinical haematology studies, ensuring the most effective and efficient conduct of the clinical trials.

This is a great opportunity to work with the AstraZeneca’s study teams in the UK, Canada and US and with your Clinical Operations colleagues at Acerta Pharma and to contribute to the quality of life of oncology patients. We offer opportunities for growth, also internationally.

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.

Global Study Associate
Oss, The Netherlands
Full-time (32-36 hours negotiable/ partly working  from home

Your challenge:
As a Global  Study Associate  you have a key role within the project teams. You will coordinate and organise all administrative and logistical tasks.  You are constantly in contact with various stakeholders ensuring that the steps within the studies are handled correctly, and within the set timelines. You will work on either early phase (phase I and II) or late phase (phase III)  haematology studies. You are involved from setting up, conducting and closing the studies and actively contribute to possible process adjustments and improvements. You are flexible and open to change and we strongly believe that the best results are achieved by team work.

What will you be doing?

  • You will initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good           Clinical Practice (ICH/GCP) and AstraZeneca SOPs.
  • You coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
  • You will coordinate study related activities and will prepare study documents, according to the applicable guidelines, SOPs and ICH-GCP.
  • You will track the progress of clinical trials, including patient recruitment, trial supplies and trial documentation according to applicable quality standards.
  • You coordinate shipping documents of suppliers (e.g. Clinical Research Organisations (CRO’s)) and monitor the approvals of site and supplier contracts.
  • You generate purchase orders, process invoices and make sure that expenses remain within the approved budget.
  • You work closely with your international colleagues in UK, Canada and US.

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.
  • Very good command of the English language (both written and verbally).
  • Competencies: you bring strong organisational skills, you are able to work accurately, proactive, and can work independently as well as in a team. You are able to keep a good overview and prioritise your work. In addition you bring strong communication skills and you are curious and eager to learn.
  • You are currently already living in the Netherlands, or have set plans to move in the short term.

What do we offer you?

  • Growth opportunities within Acerta Pharma & AstraZeneca to, for example, the position 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 + day after Ascession Day + 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.

The Team
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 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 US, Canada and UK we are committed to innovative drug discovery and development, especially in the field of haematological oncology.
Acerta 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 leukaemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines to treat haematological malignant diseases.

Application process:
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 or by phone on +31(0)85 – 047 0244.

Click here to apply

Pivot Park Captains' Dinner

10 years ago, Pivot Park opened its doors to the world. Thanks to your commitment, support and confidence, we have been able to grow it into the successful and innovative biopharmaceutical campus it is today.

Now it’s time to celebrate!

We are therefore delighted to invite you – along with all your fellow CEOs at Pivot Park – to a special night out featuring inspiring art, a wonderful dinner and lots of opportunities to network and exchange ideas.

Erwin Wurm | Am I a House?

For the first time, the artist shows a cross-section of his work, from Narrow Furniture to One Minute Sculptures, within the walls of a historic building. Villa Constance, a former home that today houses Museum Jan Cunen, is not only a location but also part of the conversation. Because what exactly is a house?


The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.