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Manager Clinical Research (m/f)

Ganymed Pharmaceuticals AG is a young and successful biopharmaceutical company located in Mainz, developing innovative antibody therapies against cancer.
 
At the earliest possible point in time, the following vacancy is to be filled:
 
Manager Clinical Research (m/f)
(employed or freelancer)
 
You will have the overall responsibility for our clinical studies (phase I-III), including scientific, regulatory, administrative and financial aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You will be key to communication within various in-house teams within the company and with external partners to ensure continuous oversight on project deliverables, budget, quality and timelines as well as the supervision of the project resources.
 
Responsibilities:
 
  • Support in setting up strategies regarding future development andclinical research scenarios
  • Summary of scientific information as well as intensive cooperation with external advisors and key opinion leaders for setting up clinical development plans and specific trial designs
  • Substantial input with regard to interim analyses, data evaluation and preparation of clinical study reports
  • Appropriate internal and external cooperation to assure consideration of all aspects of Ganymed’s clinical development
  • Preparation of regular status reports to the management
  • Oversight on project timelines, deliverables, quality and budget
  • Set-up and/or review of study core documents, e.g. study protocol, investigator’s brochure, patient informed consent documents etc.
  • Involved in contract negotiations with third party providers like CROs, freelance CRAs, central laboratories, etc.
 
Requirements:
 
  • University degree in medicine or natural/ life sciences
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
  • Minimum 5 years of experience in clinical trials management
  • In-depth knowledge of the indication oncology
  • Sound understanding of biostatistical parameters and evaluations
  • Refined colloquial and correspondence skills in German (written and spoken) is a plus
  • Fluent in English (written and spoken)
  • Excellent knowledge of usual software (Word, Excel, Power Point, MS Project)
  • Ready to take over responsibility, pro-active way of working and hand´s on mentality
  • Able and willing to take over trial management tasks
  • Able to motivate and lead a team
  • Able to recognise problems and provide solutions
  • Excellent organisational skills
 
The job holder is part of a competent, interactive and highly-motivated team. We offer an interesting and challenging job and the exciting occupation with innovative concepts.
 
Please send your complete application documents via e-mail to the following address, indicating the reference No. MCR3600JV
 
E-Mail: hr@ganymed.ag
 
GANYMED Pharmaceuticals AG
Human Resources
Anna Espenschied
An der Goldgrube 12
D-55131 Mainz
 

Contact detail


How to apply:
Please send your complete application documents via e-mail to the following address, indicating the reference No. MCR3600JV
 
E-Mail: hr@ganymed.ag
Send application to
GANYMED Pharmaceuticals AG
Human Resources
Anna Espenschied
An der Goldgrube 12
D-55131 Mainz
 

Job profile


Working hours
Full-Time
Contract duration
Temporary
Type of job
Specialist
Work experience
jobexperience is required
Region
Germany (Rheinland-Pfalz)
Working place
55131 Mainz
Area of expertise
Biology & Life Sciences
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