What we can offer you when you start working at Acerta Pharma as a Global Study Manager is a varied role with great personal development opportunities. You will be working with your international colleagues taking responsibility for the day-to-day operations managing and coordinating the haematological studies from A to Z.
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/remote
Fulltime (32-36-hours is also possible)
As a Global Study Manager you are responsible for the delivery of phase I – III 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 work in a cross functional international study management team, and oversee or support a variety of vendors (CRO’s, laboratories) and sites worldwide.
In addition you will be:
Coordinating and managing all the work that is required within the clinical trial(s) 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 review 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 time, 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 study operational management experience with a CRO or a pharmaceutical company.
- Excellent knowledge of ICH-GCP.
- Competencies: helicopter view, excellent communication & written skills, ‘can do mentality’ strong organisational skills, be pro-active team player, work accurately and being able to multitask.
- Excellent command of the English language (both written and verbally).
What we can offer you:
- 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.
- 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.
- You can work partly from home.
- For expat candidates we offer a good relocation package (including support for an application to the tax authorities for the 30% tax ruling).
- For our expat colleagues we offer an expat program, including a language course and the opportunity to learn more about the Dutch culture.
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 Canada, US and UK. 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.
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, Caroline van Oppen, Karin Raadschelders and Maaike Willems are happy to inform you.
firstname.lastname@example.org or by phone on +31(0)85 – 047 0244.