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Myelo Therapeutics GmbH develops innovative treatments in areas of high unmet medical needs. Our lead compound prevents Chemotherapy-induced Neutropenia, the most common and most serious side effect of anticancer therapy. Myelo Therapeutics was selected as one of the “Top 40 High Tech Ventures of the East”. The company was founded 2013 and currently has 9 employees, with offices in Berlin and Dresden.
 
To join the clinical development department in our Dresden subsidiary, we are looking for a

Clinical Trial Assistant (m/f) – half time / full time.
 
Myelo Therapeutics offers an attractive position in a challenging work environment and a lean and non-hierarchical organization. We give our employees a large degree of freedom to drive our scientific and commercial progress and to grow professionally.
 
As a first project, you will work with our clinical team on our ongoing Phase IIa, 160 patients clinical trial in Chemotherapy-induced Neutropenia. For this trial you will manage all related documents including working with the clinical team on the interim and final study report.
 
In addition, we prepare regulatory advisory meetings with FDA and EMA which both require a wide set of documents. The SOP structure needs to be refined and expanded. 
 
You are a good team player, experienced in independently managing documents for clinical trials and you have medical writing skills (English). You are familiar with ICH-GCP guidelines, as well as requirements of regulatory authorities, especially from the EU and US. You are able to think out of the box and across functional boundaries, able to interact with and collaborate with a diverse group of subject matter experts. A good sense of service, focus on high quality results, open and proactive communication, thoroughness in execution as well as an eagerness to learn new things make you a well suited candidate.
 
Specifically, your area of responsibility will be:
  • Create and maintain Study Files (hard-copy and electronic)
  • Arrange meetings (Data Safety Monitoring Board, Steering Committee, Investigator Meeting, Regulatory preparation meetings)
  • Facilitate purchase orders and track clinical supply inventory
  • Assist in preparation of regulatory binders, study (hard-copy and electronic)
  • Responsible for maintaining and communicating metrics via study trackers
  • Responsible for collecting, tracking and archiving Essential Documents
  • Slide preparation and protocol writing for R&D Meetings
  • Preparation of documents/ spreadsheets for data reviews
 
Your profile:
  • Bachelor’s degree or equivalent combination of education and work experience in science related field
  • Excellent demonstrable verbal and written communication skills
  • Able to work within a team with a service and excellence oriented approach
  • Able to prioritize and multi-task. Flexible, able to adapt to changing priorities
  • Attention to detail
  • Highly self-motivated and independent in our rather virtual company set-up with colleagues around the globe
  • Proficiency with MS Word, Excel, Outlook, and Powerpoint with particular emphasis on Excel
 
The position requires in average 1 to 2 days/week presence in our Dresden office, as well as approx. 2-3 days of traveling/month.
 
Besides those requirements, we have a flexible home office policy.  Currently we look rather for a half-time position but would consider full-time candidates if they can take over a sufficient range of tasks that may go beyond a clinical trial assistant role.
 
If necessary, we can support you in obtaining a German work visa.

Please send your CV along with your expected salary and earliest date of availability.

We offer a young, open-minded and ambitious international team, that has fast tracked a demanding development program in the area of oncology. We usually speak English (with all kind of accents), but in some cases some German comes in handy.

We look forward to getting to know you!

Kontaktdaten


Art des Bewerbungszugangs
Email.
Kontakt für Bewerbungen
Myelo Therapeutics GmbH
Att: Dirk Pleimes
careers@myelotherapeutics.com
Großenhainer Straße 227, 01129 Dresden
www.myelotherapeutics.com

Details der Stellenanzeige


Arbeitszeit
Vollzeit oder Teilzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Fachkraft
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Sachsen)
Arbeitsort
01129 Dresden
Fachgebiet
Humanmedizin, Biologie & Life Sciences, Mathematik
JETZT BEWERBEN