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Coopers Group AG
Clinical Trial Manager (m/f/d)Coopers Group AG • Basel-Stadt, Switzerland
Clinical Trial Manager (m/f/d)

Clinical Trial Manager (m/f/d)

Coopers Group AG • Basel-Stadt, Switzerland
Vor 21 Stunden
Stellenbeschreibung

Contract duration: until ..6 (possible extension)

Location: Basel (on-site)

Travel: Up to %

Responsibilities:

  • Serves as a core member of the Global Clinical Trial Team and secure that the region US/CA, EU, LatAm and/or AsiaPac (to which they cover) perspective is considered in relevant aspects of the global set-up and management of the trial(s).
  • Contributes to the review of key regional documents (e.g. FDA/IRB, CTA/EC or other regulatory submission packages, country/site ICF, and others) to support expeditious operational site set-up.
  • Reviews EC/IRB submission responses and facilitate quick feedback.
  • Works with the Regional/Country CRO team and acts as their primary point of contact.
  • Key partner to the trial sites, particularly with the Clinical Research Coordinator staff (e.g. study coordinators/nurses, pharmacists, contracts managers, nutritionists, etc)
  • Supports in set-up and monitoring of Regional/Country site milestones and metrics including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs)
  • Upon request from gCTM, can coordinate a team of rCTMs in review of Regional/Country site milestones and metrics
  • Actively monitors protocol deviations of Regional/Country sites and addresses/escalates potential risks and issues.
  • Upon request from gCTM and in alignment with study Medical Lead, can coordinate a team of rCTMs in monitoring and assessment of protocol deviations to address/escalate potential risks and issues
  • Collaborates and drives team to develop and implement contingencies for risk mitigation.
  • Identifies opportunities to accelerate trial start-up activities within the region and collaborates with the team on developing actions around these opportunities.
  • Participates in Site Selection Visits and leads assessment, securing input from other relevant functions as needed.
  • Participates in Site Initiation Visits and monitoring visits (as needed).
  • Performs monitoring oversight visits with CRO monitors to ensure study personnel are appropriate
  • Participates in site audits when required and aids in CAPA implementation
  • Works with sites and QA to ensure clinical trial sites are inspection ready
  • Participates in protocol development and master/local ICF process (reviewer)

Experience:

  • Bachelor’s degree with years of pharmaceutical/Biotech clinical development experience.
  • The ideal candidate has very broad experience in Regional level clinical trial management
  • Must have significant experience managing regional/country aspects of activities in Phase I-IV trials, oversight of CROs and vendors.
  • Advantageous to have rare disease trial experience.
  • Proven ability to effectively collaborate with a large group of interdisciplinary teams and Vendors
  • Strong proficiency in GCP/ICH and regulatory issues is essential
  • Up to % travel may be required
Jobalert für diese Suche erstellen

Clinical Trial Manager (m/f/d) • Basel-Stadt, Switzerland

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