Clinical Operations in haematology is expanding! For phase I – III studies we are looking for a Global Study Associate for Acerta Pharma in The Netherlands, Oss.
As a Global Study Associate, you are the linking pin for international clinical haematology 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, Canada 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.
Acerta Pharma is a member of the AstraZeneca Group and together we work on our combined haematology pipeline compounds. Because of this intense collaboration with AstraZeneca, Acerta Clinical Operations plays a significant role in drug development in haematology.
Global Study Associate
Oss, The Netherlands
Full-time (32-36 hours negotiable/ partly working from home
As a Global Study Associate you have a key role within the project teams. You will coordinate and organise all administrative and logistical tasks. You are constantly in contact with various stakeholders ensuring that the steps within the studies are handled correctly, and within the set timelines. You will work on either early phase (phase I and II) or late phase (phase III) haematology studies. You are involved from setting up, conducting and closing the studies and actively contribute to possible process adjustments and improvements. You are flexible and open to change and we strongly believe that the best results are achieved by team work.
What will you be doing?
- You will initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AstraZeneca SOPs.
- You coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
- 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 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 UK, Canada and US.
What do you bring?
- Bachelor or Master in (Bio)Medical Sciences, Chemistry, Pharmacology, Life Sciences or related study.
- At least 1 year relevant working experience with logistical and administrative guidance of clinical trials.
- At least 1 year experience working at a CRO, Academic Hospital or other pharmaceutical company.
- Experience with ICH-GCP guidelines.
- Experience with eTMF.
- Very good command of the English language (both written and verbally).
- Competencies: you bring strong organisational skills, you are 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 you 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 haematology drugs.
- Excellent working atmosphere: a high professional team 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 secondary benefits including 8% holiday allowance, 25 holidays on a full-time basis. Additional: office closure between X-mas and New Year + day after Ascession Day + Good Friday. Collective pension with a fixed percentage personal contribution, bonus scheme.
- Vitality of our colleagues is important to us, which is why you can exercise with discount or make use of our bicycle plan. You can partly work from home.
- 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 >25 experienced professionals in various roles. We work closely with AstraZeneca’s Haematology Clinical Operations teams in UK, CAN and US. 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, 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 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 Maaike Willems can be reached at firstname.lastname@example.org or by phone on +31(0)85 – 047 0244.
Click here to apply