Global Clinical Study Manager
- Experience Level
- Experienced (non-manager)
The Clinical Operations Team in Early Oncology is expanding! We are looking for a new Global Clinical Study Manager at Acerta Pharma in Oss, The Netherlands.
Acerta Pharma is a member of the AstraZeneca Group and together we work on a wide early oncology pipeline, where Acerta Clinical Operations play a significant role in drug development and study operations.
This is a great opportunity for you to bring clinical operations experience to our science driven and patient centric global study teams. You will work in a vibrant and dynamic international team. As a key member of the cross functional study team, you will be responsible for delivering and managing the operational activities of one or multiple studies.
Global Clinical Study Manager
Full-time (32-36-hour working week negotiable)
As a Global Clinical Study Manager you will be working on the delivery of phase I/II clinical oncology studies ensuring quality and compliance. In the portfolio we have a big variety of studies like First Time in Human studies, big platform studies, DDI studies as well as small studies with healthy volunteers. You will work with (combinations of) targeted therapy, immune oncology and in the near future with CAR-T compounds. In addition you will work in a cross-functional study management team with colleagues from various departments including Regulatory, Data Management, Statistics, Programming, Safety, Translation Science and Medical Writing. You will also closely manage vendors such as CRO's, laboratories and various sites worldwide.
In this role you will report to one of the Group Associate Directors Clinical Operations who is also based at our offices in Oss. Depending on the complexity of the project, you might operationally also report to a Senior Global Study Manager or a Global Study Leader who may be based in Oss (NL), UK or US.
What will you be doing?
You coordinate and manage all the work required within the clinical trial(s), including:
• Reviewing the clinical research protocol, writing/reviewing plans, ICFs and other study-related documents.
• Managing one or more vendors (CRO; central laboratories, imaging vendor etc.)including, contract review and negotiation for scope of work.
• Keep an overview on 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.
• Monitoring deadlines for internal team members and external vendors.
• Supporting Regulatory and Ethical submissions.
• Managing eTMF
• Supporting preparation and completing audits and inspections.
What do you bring?
• Minimum Bachelor's degree in Biomedical Sciences or related studies.
• At least 3 years of clinical study experience with a CRO or a pharmaceutical company is a must.
• Excellent knowledge of ICH-GCP.
• Experience in oncology is preferred.
• Competencies: helicopter view, excellent communication & written skills, ‘can do mentality’, strong organizational skills, be pro-active, work accurately and being able to multitask. In addition you have attention to details, excellent problem solving skills and able to manage priorities.
• Excellent knowledge of the English language (both written and verbally). It would be a benefit if you speak Dutch.
You are currently living in the Netherlands or willing to relocate to Utrecht, Gelderland, Noord-Brabant or Limburg.
What do we offer you?
• Dynamic, innovative and international working environment. You are part of the journey to bring new treatment options to patient that can make a difference for them and their loved ones.
• The opportunity to really develop yourself! Talent development and coaching are important for us.
• The opportunity to work in a vibrant, diverse and international team, where you can learn and grow. There is a great atmosphere which we believe is important for working as a team, constantly motivating each another.
• The opportunity to develop and grow with a clear career path.
• Good salary and good benefits including 8% holiday allowance, 25 days' leave on a full-time basis. You can work from home 1 day a week, collective pension with a fixed percentage, bonus scheme and laptop. Wellbeing of our colleagues is important to us, which is why you can exercise at a discount or make use our bicycle plan.
You will work in the Clinical Operations Team in Oss which consists of around 20 experienced professionals in various roles. We work closely with AstraZeneca's Early Oncology Clinical Operations teams in Cambridge and Gaithersburg. The culture is informal, a great team spirit and a willingness to share and learn from each other. We all work with the same goal: to bring new treatment options that make a difference in patients' life.
The team is looking forward to welcoming new, energetic, experienced and inquisitive colleagues.
At our international headquarters in Oss, over 60 colleagues are working hard to develop new treatment options for patients with specific types of (blood) cancer. We are committed to innovative drug research and development, especially in the field of hematologic oncology.
We work closely with AstraZeneca, which acquired a majority stake in Acerta Pharma in February 2016. In the meantime, we have approval from both the US (FDA) and the European Regulator (EMA) for our treatment for patients with chronic lymphocytic leukaemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines with small molecules and biologic drugs to treat certain oncological diseases.
If you have any questions about this vacancy, our Recruitment Team, Caroline van Oppen, Karin Raadschelders and Maaike Willems can be reached at email@example.com or by phone on +31(0)85 - 047 0244.