MTA, PTA, Laboratory Technician, Study Nurse as Clinical Trial Associate - Oncology, Immune Oncology (m/f/d)

Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France, Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ.

Immutep is hiring:

Clinical Trial Associate (m/f/d)

Location: Berlin, Germany; office based, 75-100 % negotiable

Summary: As a result of continuous progress in our projects we want to expand our team and therefore seek a Clinical Trial Associate. You will work closely with clinical trial manager to support the execution and maintenance of clinical trials within a global environment. Your responsibility includes to support clinical trials by maintaining organized files, communicating routinely with CROs, and collaborators in the clinical research program. This implies the supporting of national and international projects under consideration of local laws, international guidelines (ICH GCP) and applicable SOPs.

Job description:

  • Support the clinical team with tasks related to study management from start-up to study completion
  • Responsible for the internal part of the trial master file (TMF)
  • Assist the clinical team interacting with CROs and collaborators
  • Providing overall support to the clinical team e.g. prepare presentations, status reports etc.
  • Assist with regulatory submission preparation
  • Assist and manage, maintain internal tracking systems (i.e. invoices, study status, others)
  • Contribute to clinical core documents (e.g. Investigator Brochure, Trial protocol, trial amendments, Patient information sheet and consent form, Case report forms and others)
  • Support investigator meetings
  • Assist in Co-Monitoring visits, if applicable
  • Support preparation, conduct and follow-up of GCP audits and GCP inspections

Skills/Experiences/Qualifications:

  • Natural/ life sciences background (experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant or university degree)
  • Very good knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
  • Minimum 1 years’ experience in clinical operations (preferably as a CTA or CRA)
  • Refined colloquial and correspondence skills in English (written and spoken)
  • German is a plus
  • Very good knowledge of standard software (Word, Excel, Outlook, Power Point, CTMS/EDC systems)
  • Experience in oncology, immune oncology is a plus
  • Sound understanding of clinical evaluations and regulatory affairs processes
  • General understanding of R&D processes

Job expectations:

  • Multifunctional interesting tasks in the emerging field of immune therapeutics
  • Be part of the development of a “first in class” drug
  • Highly motivated and energetic international team
  • Permanent contract, office based
  • Competitive compensation
Expected start date:
  • 1st December 2019
The post is initially limited to 2 years.

 

If you are interested in this challenging career opportunity, please send your CV, certificate of employments, salary expectations, application letter and your earliest possible entry date until October 18th, 2019 to the following e-mail address (confidentiality is of course guaranteed):

hr-germany@immutep.com

In case of questions you are welcome to contact the Berlin office via +49 30 88629215.

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Über Immutep GmbH

We are a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, with operations in Europe, Australia, and the U.S. We are the global leader in the understanding of and in the development of therapeutics that modulate Lymphocyte Activation Gene-3 (“LAG-3”), a cell surface molecule which plays a vital role in regulating T cells and which was...
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