Global Study Manager Haematology

Are you ready to drive global clinical studies that truly change patients lives

At Acerta Pharma a member of the AstraZeneca Group we are dedicated to transforming the treatment landscape for patients with haematological malignancies. We are now looking for a proactive and globally minded Global Study Manager to join our Clinical Operations Team and take ownership of international haematology studies from early development through to late phase.

This is a high impact role with strong visibility international collaboration and personal development opportunities.

Global Study Manager
Haematology Clinical Operations full time
Oss Amsterdam

Acerta Pharma will be relocating to Amsterdam with the current move planned for early 2027. Until that time the working arrangement will be as follows: employees will work 12 days per week from the Oss location 12 days from the Amsterdam office and the remaining days from home. This schedule results in an overall office presence of 60%.

Your impact
As a Global Study Manager you deliver delegated aspects of the clinical study in accordance with the Global Study Director (GSD) or Global Study Associate Director (GSAD).

Our portfolio ranges from First in Human and Phase I trials to Phase II and registrational studies. Your role will be aligned with the Study Team Operating Model for Insourced or Outsourced Delivery current clinical trial regulations (e.g. ICH GCP) AstraZeneca Standard Operating Procedures (AZ SOPs).

You will:
Support & coordinate global haematology studies from protocol development through to CSR and archiving
Ensure the supply of Investigational product and study materials by liaising with Global Clinical Supply or external service providers as appropriate.
Supports GSADs in project management as per agreed delegation.
Support the study team in the implementation of audits and regulatory inspections.
Drive start-up activities and oversee early phase execution
Provide country and vendor oversight (e.g. imaging labs IRT e-Pro CRO)
Manage vendor contracts budgets and change orders
Oversee study documentation (ICF CSA country specific documents vendor specifications)
Ensure inspection readiness through compliance to ICH-GCP and global regulations
Identify risks proactively and drive issue resolution across regions
Collaborate cross functionally with Clinical Operations Regulatory Data Management Patient Safety Supply Chain and Procurement
Contribute to process improvements innovation initiatives and operational excellence.

This is a truly global remit operating across all AstraZeneca countries.

Innovation & Digital mindset
We are accelerating digital transformation within Clinical Operations. Therefore experience with AI tools automation or digital process optimisation is mandatory.

You bring:
Hands-on experience applying AI or automation in Clinical Operations
A mindset focused on efficiency scalability and smart data usage
The ability to identify opportunities to improve processes through technology

What do you bring
Bachelors / Masters degree in Biomedical Sciences Chemistry Pharmacology Life Science or related studies.
Minimum of 5 years of recent clinical research experience
At least 3 years of clinical development project management experience
Strong start up and phase I and/or phase II experience (phase III experience is a plus)
Therapeutic experience in haematology preferred
Vendor management experience
Excellent knowledge of ICH-GCP and global regulatory frameworks
Excellent communication and interpersonal skills.
Strong matrix leadership and stakeholder management skills
Strategic thinking with strong organisational and problem solving skills
Ability to manage competing priorities.
Fluent English (written & spoken)
Currently living in the Netherlands with a valid work permit

Location & office presence
Hybrid working model
Until we move to Amsterdam currently scheduled for early 2027 (60% office based):
1-2 days per week in Oss
1-2 days per week in Amsterdam
Remaining days remote

After relocation:
60% office based in our new Amsterdam office
40% remote

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 blood cancer patients and their loved 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 27 holidays on a full-time basis plus office closure between Christmas 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.

About AstraZeneca Oncology R&D Amsterdam
At AstraZeneca Amsterdam we bring together two research groups in haemato-oncology and next-generation cell therapy research. Together they form our Oncology R&D hub in the Netherlands working closely with colleagues in the US Canada Spain and the UK to develop innovative treatments for patients with cancer.

Our hematology R&D group was born as Acerta Pharma one of the Netherlands greatest biotech success stories. Its small-molecule BTK inhibitor has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of Chronic Lymphocytic Leukaemia (CLL) and Mantle Cell Lymphoma (MCL). In Amsterdam approximately 100 colleagues continue the development of new therapies for haematological malignancies under the AstraZeneca brand name.

AstraZenecas Cell Therapy R&D team focuses on developing next-generation T-cell receptor (TCR) therapies targeting neoantigens in solid tumours. With a team of around 75 scientists we work on both fully individualised and shared neo-antigen approaches with the aim of improving outcomes for patients with cancer.

Our oncology research and development hub is anchored by our new state-of-the-art laboratories in OneHelix and the adjacent Plus Ultra Amsterdam building both located on the Amsterdam University Medical Centre (Amsterdam UMC) campus. Our hub is firmly positioned at the heart of the Dutch research community creating new opportunities for our people and science as we work to transform the lives of patients.

Apply:
If you have any questions about this vacancy our Recruitment Team Karin Raadschelders / Caroline van Oppen are happy to inform you. or by phone on 31(0)85 -.

This position will remain online until an offer has been accepted.

Date Posted

Closing Date

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.