Senior Global Clinical Study Manager
Clinical Operations in Early Oncology is expanding! For Phase I/II studies we are looking for a Senior Global Clinical Study Manager for Acerta Pharma in The Netherlands, Oss.
Acerta Pharma is a member of the AstraZeneca Group and together we work on our combined early oncology pipeline compounds. Because of this intense collaboration with AstraZeneca, Acerta Clinical Operations play a significant role in drug development in early oncology.
This is a great opportunity for you to bring your clinical operations experience to our science driven global study teams. You will work together with your colleagues from both Acerta Pharma and AstraZeneca in the UK and US. In this role you are a key member of the cross functional study team and you are responsible for delivering and managing the operational activities.
Senior Global Clinical Study Manager
Oss, The Netherlands
Full-time (32-36-hour working week negotiable)
As a Senior Global Clinical Study Manager you are responsible for managing usually one, sometimes more early phase oncology studies. You are a member of the cross functional study team and support the Study Leader who is accountable for cross functional leadership and overall study execution. You are responsible for delivering the operational activities, as well as providing guidance and support to the Global Study Managers (GSM) and Global Study Associate (GSA) assigned to the study.
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. 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 work with vendors such as CRO's, laboratories and various sites worldwide.
In this role you report functionally to one of the Group Associate Directors Clinical Operations who is also based at our offices in Oss. Operationally you will report to one of the Study Leaders who may be based in Oss, UK or USA.
What will you be doing?
You manage all the work required within the clinical study(ies), including:
• Leading and supporting Global Study Managers and Global Study Associate(s) within the study team.
• Monitoring study progress and proactively identify/resolve issues with the Study Leader in order to complete the studies within time, budget and quality requirements.
• Preparing/reviewing the clinical research protocol, writing/reviewing (monitoring) plans, ICFs and other study-related documents.
• Managing one or more vendors (monitoring vendor; central laboratories, imaging vendor etc.), including contract review and negotiation and scope of work.
• Supporting risk management and quality assurance.
• Monitoring deadlines for internal team members and external vendors.
• Guidance of Health Authority and EC submissions.
• Supporting the study team in the preparation and execution of audits and inspections.
What do you bring?
• Minimum Bachelor's degree in Biomedical Sciences or related studies.
• At least 5 years of clinical study experience with a CRO or a pharmaceutical company is a must. The ideal candidate will possess significant and progressive experience in the management of global, multi-center clinical studies.
• Excellent knowledge of ICH-GCP.
• Experience in oncology is a pre.
• Experience of working with and delivering through strategic partners and 3rd party vendors.
• Competencies: Mentoring skills, helicopter view, excellent communication and written skills, ‘can do mentality’, strong organizational skills, be pro-active, work accurately and being able to multitask. In addition you are meticulous, you have excellent problem solving skills are you are able to set priorities.
• Excellent command of the English language (both written and verbally). It would be a benefit if you speak Dutch.
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 small, 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, constantly motivating one another.
• The opportunity to develop yourself further, for example, into a position offering even more responsibility. International growth (within AstraZeneca) is also one of the possibilities.
• 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. Vitality of our colleagues is important to us, which is why you can exercise at a discount or make use our bicycle plan.
• We offer you an annual contract with the intention to extend this to an indefinite contract after one year.
You will work in the Clinical Operations Team in Oss which consists of 20 experienced professionals in various roles. We work closely with AstraZeneca's Early Oncology Clinical Operations teams in Cambridge and Gaitersburgh. 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, more than 60 colleagues are working hard to develop new treatment options for patients with specific types of (blood) cancer. Together with our colleagues at our American subsidiary in San Francisco, we are committed to innovative drug research and development, especially in the field of hematological oncology.
In addition, we work closely with AstraZeneca, which acquired a majority stake in Acerta Pharma in February 2016. Since the U.S. Food and Drug Administration (FDA) granted accelerated approval for our drug for previously treated mantle cell lymphoma (MCL) patients at the end of October 2017, we have been working together to get approval for patients around the world. 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 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 Cynthia Smit can be reached at firstname.lastname@example.org 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 authorisation and employment eligibility verification requirements.