Beschreibung
Stellenbeschreibung: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 and clinical 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
Details:
40 Stunden pro Woche
Stundensatz: nach Vereinbarung & Erfahrung
Laufzeit: 6-12 Monate
Für weitere Details können Sie mich gerne telefonisch oder per Email erreichen. Bitte senden Sie mir noch Ihren aktuellen Lebenslauf zu!
Ich freue mich von Ihnen zu hören!
Sonnige Grüße aus München,
Carla Störzer
Für mehr Informationen über Progressive Recruitment besuchen Sie www.progressiverecruitment.com/de.