Are you an experienced Clinical Research Associate (CRA) ready for your next step in your career as a Global Study Manager at Acerta Pharma in Oss, The Netherlands?
We have a great varied role available in our Clinical Operations team with great personal development opportunities. You will be working with your international colleagues taking responsibility for the coordination of haematological studies worldwide.
Acerta Pharma is a member of the AstraZeneca Group and together we work tirelessly to bring new therapies to patients in need with haematological malignancies.
Global Study Manager
Oss, The Netherlands (office based 3 days per week)
Full-time (32-36-hours is negotiable)
• As a Global Study Manager you are responsible for the delivery of phase I clinical haematology studies ensuring quality and compliance. Our portfolio consists of a big variety of studies ranging from First Time in Human to registrational studies.
• You will be working in a cross functional international study management team, overseeing or supporting a variety of vendors (CRO’s, laboratories) and sites worldwide.
• In addition you will be coordinating all the work that is required within the clinical trial process including: leading 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.
• Managing one or more vendors including contract reviews and negotiations.
• Managing one or more countries where the study is conducted.
• Keeping an overview of output and progress of the studies, proactively identifying and resolving issues to complete the studies within timelines, budget and quality requirements.
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 operations experience with a CRO or pharmaceutical company.
• Excellent knowledge of ICH-GCP.
• Effective communicator aimed towards collaboration and accountability. Excellent command of the English language (both written and verbally).
• You are currently already living in the Netherlands or you have set plans to move to the Netherlands.
What we offer
A dynamic, innovative and international working environment. You are part of the development process of new drugs that can make a difference in the lives of cancer patients and their loved ones. In addition:
• 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 primary & secondary benefits including 8% holiday allowance, 25 holidays on a full-time basis plus office closure between X-mas and New Year + Good Friday.
• Collective pension with a fixed percentage personal contribution.
• Bonus scheme.
• Personal budget which can be used for vitality, home office equipment, sustainability or personal development.
• Access to internal training and learning and development offerings.
• Working from the office 3 days per week, 2 days remote.
For expat candidates we offer
• a relocation package (including support for the application to the tax authorities for the 30% tax ruling).
• an expat program, including a Dutch language course and the opportunity to learn more about the Dutch culture.
You will be working in our 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 Canada, US and UK.
The culture in Oss is informal, there is 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.
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.
If you have any questions about this vacancy, our Recruitment Team, Karin Raadschelders / Caroline van Oppen are happy to inform you: email@example.com 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.