Detail

Salary
negotiable
Location
Utrecht, Netherlands
Posted by: Astra Zeneca
01 May
8 Views
30 Jun expires

Global Study Manager

Utrecht, Netherlands
Job Description

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.

Job ID Reference
1499
Desired Skills & Experience

   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.

Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Utrecht, Netherlands