Clinical Trial Project Manager (CTPM) (m/f)

in Switzerland  ‐ Vor Ort
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Schlagworte

Beschreibung

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 Project Manager (CTPM) (m/f)

Referenz: -en
Beginn: 06/10
Dauer: 12 MM++
Ort: in Switzerland
Branche: Herstellung von pharmazeutischen Erzeugnissen

Ihre Aufgaben:
  • Drive the global operational activities of one or more protocol(s) using advanced management and organizational skills
  • Interact with the cross-functional team members to ensure timelines, deliverables and data quality are met within budget
  • Effectively lead a global team of individuals assigned to the protocol(s) and delegate appropriate tasks, assignments and responsibilities
  • Coordinate the development of protocol(s) level documents and plans and ensure product/program standards are implemented on the protocol level
  • Provide mentoring, guidance, coaching, and feedback to global operations team members
  • Lead and oversee the successful and efficient project management of the protocol(s) from study start up to Trial Master File archiving
  • Ensure clinical trial team (CTT) and global operations team (GOT) are aligned with the department objectives
  • Monitor and implement corrective actions for the protocol(s) progress using available study management tools
  • Identify and develop risk management and contingency plans
  • Create, coordinate, review and/or provide input into study clinical documents
  • Lead and oversee the operational component of vendor selection
  • Liaise with cross-functional team members (e.g. Drug Safety, DRA, CTSM, Biometry, etc.) to ensure timely creation of protocol
  • Coordinate with the Technical Operations group to ensure protocol clinical supply needs are met
  • Work with Data Management and Science to ensure database availability, CRF printing, collection of CRFs and queries (CRF and Query Locks), database audits (1,000 checks) and other database lock activities according to previously approved timelines
  • Collaborate with Legal to develop study Investigator budgets and contract templates across the trial and then specifically for each unique region / country
  • Ensure the clinical trial is adhering to the regulations and guidelines globally and locally in each region/country
  • International travel is required


Ihre Qualifikation
  • University degree in either a biological science or healthcare profession
  • Global Clinical Trial Management experience is preferred
  • Thorough knowledge of ICH / GCP guidelines and including international regulatory requirements for the conduct of clinical development programs
  • Strong project management skills with proven team building skills
  • Regional monitor experience required
  • Advanced computer skills
  • Effective oral and written communication skills
  • Ability to delegate effectively
  • Ability to run complex studies internationally / globally
  • Fluent in English (additional languages advantageous)



Skills:
- Clinical Project Management


Keywords: "Clinical Trial Project Manager" "Clinical Trial Manager" "CTPM" "CTM"
Start
06/10
Dauer
12 MM++
(Verlängerung möglich)
Von
Hays AG
Eingestellt
12.05.2010
Ansprechpartner:
Katharina Tuschhoff-M?ller
Projekt-ID:
151144
Vertragsart
Freiberuflich
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