Global Clinical Study Associate
For our growing Clinical Operations department at Acerta Pharma in Oss, a member of the AstraZeneca group, we are looking to expand our team with talented new Global Clinical Study Associates.
As a Global Clinical Study Associate, you are the ‘spider in the web’ for international clinical oncology studies, ensuring the most effective and efficient conduct of the clinical trials.
This is a great opportunity to work with the AstraZeneca's study teams in the UK and US and with your Clinical Operations colleagues at Acerta Pharma and to contribute to the quality of life of oncology patients. We offer opportunities for growth, also internationally.
Global Clinical Study Associate
Full-time (40 hours) 4 days a week is negotiable
(including occasional out-of-hours meetings due to the time differences with our international colleagues)
What are you going to do?
As a Global Clinical Study Associate (internally, this position is called: Global Study Associate) you have a key role within the project teams. You will coordinate and organise all administrative and logistical tasks and you are in contact with various stakeholders ensuring that the steps within the studies are handled correctly and within the set timelines. On average, you will work on 4 early phase (phase I and II) oncology studies at the same time. You are involved from A-to-Z in the studies and actively contribute to possible process adjustments and improvements. That's why it's important to be flexible and open to change. The best results are achieved by team work!
Tasks and responsibilities:
• You will assist the global study team with administrative and logistical tasks in setting up, conducting and closing clinical trials.
• You will coordinate study related activities and will prepare study documents, according to the applicable guidelines, SOPs and ICH-GCP.
• You will track the progress of clinical trials, including patient recruitment, trial supplies and trial documentation according to applicable quality standards.
• You are responsible for keeping study documents up-to-date and archiving these in the eTMF.
• You coordinate shipping documents of suppliers (e.g. Clinical Research Organisations (CRO’s)) and monitor the approvals of site and supplier contracts.
• You generate purchase orders, process invoices and make sure that expenses remain within the approved budget.
• You work closely with your international colleagues in Cambridge (UK) and/or Gaithersburg (US).
What do we ask of you?
• Bachelor or Master in (Bio)Medical Sciences, Chemistry, Pharmacology, Life Sciences or related study.
• At least 1 year of relevant work experience with logistical and administrative guidance of clinical trials.
• At least 1 year of experience at a CRO, Academic Hospital or other pharmaceutical company.
• Experience with ICH-GCP guidelines.
• Experience with eTMF is a plus.
• Very good command of the English language (both written and verbally), Dutch would be a benefit.
• Competencies: you are an organisational talent, able to work accurately, proactive, and can work independently as well as in a team. You are able to keep a good overview and prioritise your work. In addition you bring strong communication skills and are curious and eager to learn.
• You are currently already living in the Netherlands, or have set plans to move in the short term.
What do we offer you?
• Growth opportunities within Acerta Pharma & AstraZeneca to, for example, the position of Global Study Manager. There are also international growth opportunities.
• The opportunity to work together in a large, committed, experienced and international team, where you can learn all about the development of oncology drugs.
• Excellent working atmosphere: a new team within an existing organisation with great team spirit. Meaning, play to win, helping each other where you can and room for fun things besides work (monthly drinks, joint lunches, outings with the team).
• Good salary and good benefits, including 8% holiday allowance, 25 days of leave on a full-time basis, collective pension with a fixed percentage, bonus scheme and laptop. You can work from home 1 day a week. Vitality of our colleagues is important to us, which is why you can exercise at a discount or use our cycling plan.
• Annual contract with the intention to convert this to a permanent 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 and ambitious, 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 looks forward to welcoming new, energetic, experienced and inquisitive colleagues.
About Acerta Pharma
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 you want to apply, we would like to receive your CV and motivation letter in English. For this, go to the apply button at the bottom of this vacancy. 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 and Karin Raadschelders ) can be reached via firstname.lastname@example.org or on +31(0)85 - 047 0244.
In connection with corona, the (first) conversations take place via Teams or Zoom. Acquisition by recruitment and selection agencies is not appreciated.
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.