AstraZeneca Pharmaceuticals LP Clinical Trial Assistant in Oss, Netherlands
Do you have a Bachelors or Masters degree in (Bio)Medical Sciences or related study?
Relevant work experience within an international pharmaceutical company and/or within Clinical Trial Operations? Are you familiar with eTMF (filing)? Can you work very accurately?
If so, please read on, because we at Acerta Pharma are looking for an ambitious colleague for our small and strong Clinical Operations Team.
Clinical Trial Assistant (CTA) with growth possibilities
Fulltime (40 hours) while 4 days per week is negotiable
(includes outside office hours on occasional basis)
What are you going to do?
As a Clinical Trial Assistant, you have a key role within the Clinical Operations Department. You coordinate and organize all the administrative tasks in clinical studies and you have contact with all stakeholders (by email and phone) to make sure that all steps within the study are handled correctly and within the timeframe.
Tasks & responsibilities:
Assist the global study team with administrative tasks in clinical study set-up, execution and close-out.
Set up internal study team meetings and write meeting minutes.
Track the progress of assigned clinical studies, such as study subject enrollment and site visits, eCRF data entry, essential documents, monitor visits and reports, IMP and blood sample logistics.
Are responsible for maintaining up to date study documents (including FDFs, CVs, 1572s) and filing in the eTMF.
Coordinate shipment of documents and materials to clinical trial sites and vendors as needed.
Coordinate Contracts Approvals, including obtaining appropriate approvals and signatures for site contracts and vendor contracts.
Prepare, request and track Purchase Orders for contracted services.
What do we ask from you?
Bachelor or Master degree in (Bio)Medical Sciences, Physics, Chemistry, Pharmacology or related study.
Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory.
Experience with eTMF
Fluent in English and Dutch.
Residence in the Netherlands, preferably living within 50 km from the office in Oss (for example: Nijmegen, Utrecht, Eindhoven)
Minimum of 1-2 year relevant experience within a pharmaceutical company, Clinical Research Organization or a hospital (valuable experience as an Intern is acceptable).
Competences: great communicator, ambition, fast learner, flexible, helpful, eager to take on new tasks, helicopter view, organizational talent.
What do we offer you?
Growth possibilities within Acerta Pharma, (i.e. Clinical Research Analyst) depending on your education and background.
A dynamic, innovative, international working environment, to let you be a part of the development of new haematologic medicines which can make the difference to the life of patients.
The possibility to work in a small, dedicated, well-experienced team where you can learn everything about drug development.
A very nice team with great team spirit! Which includes driving for the best result; helping each other out where we can; and room for leisure (monthly company drinks; celebrations; lunches; global yearly summit).
A good salary and good secondary benefits including 8% holiday allowance; 25 vacation days per year on a fulltime basis; collective pension with a fixed percentage; bonus package. Laptop and cell phone.
A one-year contract with the intention to extend it to a permanent contract.
The Clinical Operations Team in Oss is a team of 8 well-experienced professionals (2 CTAs, 2 CRAs, 2 CTMs, administrative assistant and Associate Director/group head), part of the wider, global Clinical Operations group based in South San Francisco. The culture is informal, a great team spirit, and willingness to share and learn from each other and the team is looking forward to welcoming a new, energetic and eager-to-learn colleague.
Acerta Pharma B.V. was founded in 2012 by Allard Kaptein, Tjeerd Barf, Ahmed Hamdy, Raquel Izumi, and Francisco Salva. Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer.
Around 200 people work at Acerta Pharma, divided over 3 locations, one at the Pivot Park in Oss in The Netherlands, and two in the US (San Carlos and South San Francisco). In Oss there are about 25 enthusiastic, inspired colleagues working every day on drug discovery and development, together with the teams in the US in order to bring new treatment options to patients.
After reporting highly promising data from a phase 1b/2a study in chronic lymphocytic leukemia patients in 2015, the company received a lot of attention. In February 2016, AstraZeneca acquired a majority share (55%) of Acerta Pharma and is a committed partner for the haematologic oncology field. At the end of October 2017, the US Food and Drug Administration (FDA) granted accelerated approval in the USA for acalabrutinib for previously treated mantle cell lymphoma (MCL) patients. Acerta Pharma together with AstraZeneca are now working hard towards approval for other countries and for additional indications for this drug.