Careers

We provide an attractive working environment
for highly motivated and committed employees
in a rapidly growing company.

 
 
     
 
  Job Advertisement  
     
  Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases.  
     
 

To strengthen our highly motivated team in Heidelberg, Germany, we are looking for a

Clinical Trial Assistant (f/m)
(Reference No. C01)

 
 

Responsibilities:

  • Set up, maintain and review trial master files including supporting quality control of documents
  • Support the Clinical Team in all aspects of the organization and management of clinical trials according to ICH-GCP, applicable regulations and SOPs
  • Support Trial Team in generating and updating trial related documents and manuals
  • Provide support in compilation and submission of packages for clinical trial applications to Health Authorities and Ethics Committees/Institutional Review Boards
  • Support in all administrative tasks in the context of clinical trials
  • Accurately monitor, update and maintain trial status and overview lists
  • Track status of trial-related tasks
  • Support trial-related invoicing and budgeting
  • Run contract management for Clinical Department: preparation of contractual documents, shipment, follow-up on return of documents, as well as filing, archiving and maintenance of internal database
  • Correspond with internal and external partners and vendors
  • Support the organization and coordination of internal and external meetings
  • Prepare and review meeting minutes
  • Collaborate with the Clinical Department in definition and development of internal processes, e.g.SOP writing

Requirements:

  • Scientific degree, medical documentation officer certification or equivalent medical, scientific or pharmaceutical education
  • Long-term experience as Clinical Trial Assistant in biotech/pharmaceutical industry or at a CRO
  • Very good knowledge of ICH-GCP and regulations governing the conduct of clinical trials
  • Very good English skills, both written and spoken
  • Excellent communication skills
  • Very good organizational skills and team spirit
  • Results-oriented approach, flexible and proactive attitude towards changing needs; willingness to work on different projects simultaneously
  • Ability to systematically perform activities in a timely and accurate manner, reliability, good time management
  • Ability to work in a structured manner even under time pressure, experience in dealing with external parties
  • Ability to confidentially handle sensitive data and information
  • Knowledge of the current national and international laws and guidelines regarding the conduct of clinical trials, specifically with ICH-GCP
  • Very good knowledge of MS Office

Opportunity:

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team.

For any queries, please contact Susanne Hering (Tel: 06221 6743 675, E-mail: s.hering@affimed.com).

September 2018

 
 
  Apply now by use of Reference No. C01
 
 



 
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