Global Study Manager

Our Clinical Operations team in Oss is expanding! We are currently looking for a Global Study Manager to join our team. This is a great opportunity for you to bring your clinical operations experience to our science driven global study teams.

You will be responsible for ensuring a smooth running of our Phase I – III haematology studies and you will work together with your colleagues from both Acerta Pharma and AstraZeneca in the UK, Canada and US. You are a key member of the cross functional study team and you are responsible for delivering and managing the operational activities. 

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 Manager
Oss, The Netherlands
Full-time (32-36-hours negotiable/ partly working from home)

Your challenge:
As a Global Study Manager you are supporting the delivery of phase I – III clinical haematology studies ensuring quality and compliance. In the portfolio we have a big variety of studies such as First Time in Human studies and big platform studies. You will work with combinations of targeted therapies. You will work in a cross functional study management team with colleagues from various departments including Clinical Development, Regulatory, Data Management, Statistics, Programming, Safety, Translation Science and Medical Writing. You will also closely work with vendors such as CRO’s, laboratories and various sites worldwide.

In this role you report to the Associate Director Study Management who is also based at our offices in Oss. Operationally you will report to one of the Global Study Associate Director who may be based in Oss, UK or US.

What will you be doing?
You coordinate and manage all the work required within the clinical trial(s), including:

  • Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement, country specific documents etc.) and external service provider related documents such as specifications, study specific procedures, descriptions, presentations etc..Ensuring template and version compliance.
  • Managing one or more vendors (monitoring vendor; central laboratories, imaging vendor etc.), including contract review and negotiation as well as scope of work.
  • Managing one or more countries where the study is conducted.
  • Keep an overview of output and progress of the studies, proactively identify and resolve issues to complete the studies within time, budget and quality requirements.
  • Supporting risk management and quality assurance.
  • Supporting the study team in preparation and execution of audits and inspections.

What do you bring?

  • Bachelor’s / Master’s degree in Biomedical Sciences, Chemistry, Pharmacology, Life Science or related studies.
  • At least 3 years of clinical study experience within a CRO or a pharmaceutical company.
  • Excellent knowledge of ICH-GCP.
  • Experience in haematology and/or oncology is an advantage.
  • Competencies: helicopter view, excellent communication & written skills, ‘can do mentality’ strong organisational skills, be pro-active, work accurately and being able to multitask. In addition you are meticulous, you have excellent problem solving skills and you are able to set priorities.
  • Excellent command of the English language (both written and verbally).

What do we offer you?

  • Dynamic, innovative and international working environment. You are part of the development of new drugs that can make a difference in the lives of cancer patients and their loved ones.
  • The opportunity to really develop yourself; talent development and coaching are important themes for us.
  • The opportunity to work in a high professional, close-knit team, where you can learn a lot from each other and count on one another. There is a great atmosphere which we believe is important for working as a team
  • The opportunity to further develop yourself, for example, into a position offering even more responsibility. International growth (within AstraZeneca) is also one of the possibilities.
  • 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 at a discount or make use of our bicycle plan. You can partly work from home.
  • For candidates from abroad we offer a good relocation package (including support for an application to tax authorities for the 30% tax ruling).
  • For our international colleagues we offer an expat program, including a language course and to learn more about the Dutch culture.

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 Toronto (CAN) US and Cambridge. The culture in Oss is informal, 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 is looking forward to welcoming new, energetic, experienced and inquisitive colleagues.

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.

Apply:
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 info@werkenbijacertapharma.nl or by phone on +31(0)85 – 047 0244.

Click here to apply

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