Clinical Trial Associate - Berlin, Deutschland - Immutep

Beschreibung

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.


Location:
Berlin, Germany office based or home office, 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 the Clinical Trial Supply and
Vendor Manager and other team members to support the execution and maintenance of clinical
trials within a global environment. Your responsibility includes support with vendor management
oversight activities related to the IMP supply chain, and support clinical trials in general by
maintaining organized files/eTMF, tracking/reporting, and 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 IMP management from startup to study

completion

• Support with IMP vendor oversight
• Responsible of tracking and reporting IMP trialspecific stock and support for other

related activities of IMP supply chain

• Assist with Clinical Trial documentation and contribute to clinical core documents mostly

related to the IMP management (e.g. Pharmacy Manual, etc)

• Providing overall support to the clinical team e.g. prepare presentations, status reports

etc

• Assist the clinical team interacting with CROs and collaborators
• Responsible for the internal part of the trial master file (TMF) Paper and electronic
• Invoice tracking for Responsible team member review
• Assist in Co-Monitoring visits, if applicable
• Support preparation, conduct and followup of GCP audits and GCP inspections

Skills/Experiences/Qualifications:

• Natural/ life sciences background (preferable Pharmaceutical Technical Assistant or

university degree)

• Minimum 2 years' experience in clinical operations (CTA or CRA level)/supply chain but if

not, it is required previous experience/good knowledge in the clinical research field, e.g.
via internship, extra formation, targeted courses, etc

• Knowledge and experience in relevant legislation and international guidelines (ICH-GCP)

for the performance of clinical research projects

• Proficiency of standard software (Word, Excel, Outlook, Power Point); CTMS/EDC

systems)

• Fluency in English (written and spoken) is mandatory. German and/or a second European

language is a plus

• Experience in oncology, immune oncology is a plus
• 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
• Competitive compensation

If you are interested in this challenging career opportunity, please send your CV, certificate of