CTA, MTA, PTA, Nurse - Clinical Trial Associate (m/w/d)

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Job description

Clinical Trial Associate (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.

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 managers (CTMs) and other project team members to support the execution and maintenance of clinical trials within a global environment. Your responsibility includes supporting vendor management, oversight activities, and support clinical trials in general by maintaining organized files, managing invoice tracking, filing critical correspondence 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.
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)
Support Lab and IMP vendor oversight
Invoice tracking for CTM/Responsible team member review
Assist the clinical team interacting with CROs and collaborators
Providing overall support to the clinical team e.g. prepare presentations, meeting minutes, status reports etc.
Assist with Clinical Trial documentation
Assist and manage, maintain internal tracking systems (i.e. invoices, study status, others)
Create and maintain study status overviews per internal plans and vendor status trackers (i.e Monitoring report review, CRO risk review, Data Management metrics…)
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 meeting
Assist in site visits, if applicable
Support preparation, conduct and follow-up of GCP audits and GCP inspections

Natural/ life sciences background (experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant or university degree)
Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
Minimum 2 years' experience in clinical operations (preferably as a CTA or CRA) would be an advantage.
Required previous experience/good knowledge in the clinical research field/clinical operations
Proficiency in English (written and spoken) German and/or a second European language is a plus
Proficiency of standard software (Word, Excel, Outlook, Power Point); CTMS/EDC systems)
Experience in oncology, immune oncology is a plus
General understanding of R&D processes

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
Competitive compensation

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