Clinical Trial Manger (m/f)

Job type:
on-site
Start:
asap
Duration:
6 MM++
From:
Hays AG
Place:
in Bavaria
Date:
04/20/2012
Country:
flag_no United Kingdom
project ID:
351544

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.


We are looking for a
Clinical Trial Manger (m/f)

Referenz: 180223/3-en
Beginn: asap
Dauer: 6 MM++
Ort: in Bavaria
Branche: Sonstige Forschung und Entwicklung im Bereich Natur-, Ingenieur-, Agrarwissenschaften und Medizin

Ihre Aufgaben:
  • Plan, implement and supervise clinical trials, work in close collaboration
  • with project leaders, clinical research physicians and other stakeholders
  • Support Clinical Operations Manager with regard to the supervision of a
  • clinical trial and assume responsibility for assigned task package (quarterly budgeting, CRO management, attending site initiation meetings, etc.)
  • Participate in CRO management and surveillance of outsourced clinical
  • trials
  • Assist in managing co-monitoring activities for assigned trials
  • and participate in co-monitoring as needed
  • Oversee execution of one or more clinical trials while ensuring that all trial
  • deliverables are met according to specified timelines, budgets, resources, etc.
  • Contribute to preparation of clinical program documents (investigator
  • brochure, IND annual report, health authority briefing books and submissions)
  • Establish and manage study plan and ensure resolution of critical issues
  • Identify areas of best practice and process improvement
  • Develop study-related documents from concept sheets to final documents
  • Define, negotiate and ensure execution of study-related agreements, such
  • as clinical trial agreements, CROs, central lab services, etc.


Ihre Qualifikation
  • Profound professional experience in multinational clinical trial management, focusing on the pharmaceutical or biotech industry
  • Proven track record of compiling clinical study protocols, reports and publications
  • Demonstrable expertise relating to all aspects of the clinical development process
  • Ability to identify and resolve complex methodological issues relating to clinical trials
  • Well-developed organizational and interpersonal skills, complemented by attention to detail
  • Good knowledge of GCP and regulatory requirements (especially FDA and
  • EMEA)
  • Finely honed written and verbal communication skills, underpinned by the ability to present clear instructions/directions to teams within the organization
  • Willingness to travel (approx. 25%)



Skills:
- Clinical Project Management