106 days ago on ctcon.ch

Global Trial Manager

CTC Clinical Trial Consulting AG

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  • Employment type
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 Please refer to JobSuchmaschine in your application

Global Trial Manager

Reference Number: 895032-W
Type of placement: Contract, 12 months
Location: Switzerland, North West


The GTM will work closely with groups within Global Clinical Operations (GCO) (e.g. Regional, Documentation, Administrative, Operations and Excellence) and with cross functional groups as required. For large Phase III or complicated trials, a GTM will be assigned to a trial to support the Global Trial Leader with the management and handling of GCO deliverables. The GTM will represent the Trial Management and Support Group and provide consolidated updates to the GTL. For Phase II trials, an experienced GTM can manage the GCO deliverables with minimal or no oversight from a GTL.

Main Responsibilities:

  • Lead and provide direction to the assigned Global Clinical Project Management (GCPM) team on a global basis to ensure all operational trial output from trial start-up to archiving of the (e)Trial Master File are delivered on time, within budget, and with highest achievable quality
  • Represent the assigned GCPM team at Clinical Trial Team meetings
  • Chair meetings of the GCPM team, ensure a two-way flow of information is maintained between the GCPM team and the Clinical Trial Teams, and ensure timely follow up on agreed upon actions
  • Ensure global thinking among group members
  • Ensure adequate trial-specific training of the assigned GCPM team
  • Supervise  and  participate  in  the  selection  and  contracting  of  External  Service  Providers (e.g., Contract Research Organization, central laboratory, Electronic Data Capture, electronic Patient Reported Outcome, Interactive Voice and Web Response System), ensure their adequate training, and manage their performance and costs
  • Create the global investigator budget/financial plan including guidelines for site budgets and payment schedules as appropriate
  • Contribute  to  preparation  and/or  review  of  all  trial-related  documents  (e.g.,  protocol,  site  and monitoring guidelines) in collaboration with other team members
  • Forecast global supply needs, order supplies, and ensure timely distribution globally (IMP and other materials)
  • Organize and supervise the preparatory activities for the Investigator meetings as well as participate and present at the meetings
  • Contribute to monitor trainings
  • Develop and implement risk assessment and contingency plans, and proactively identify new risk plans for operational deliverables in collaboration with the Global Trial Leader
  • Manage trial activities and ensure delivery of global operational output in accordance with the Clinical Trial Plan, timelines, and budget
  • Ensure consistency of processes and tools used across regions
  • Compile key performance indicators (e.g., site initiation, patient recruitment, data collection, and query resolution)
  • Proactively identify and resolve issues with external service providers in a timely and efficient manner
  • Coordinate pre-audit activities to meet satisfactory outcomes
  • Ensure trial information is kept up to date in clinical trial management and documentation systems
  • Ensure completeness and audit-readiness of the Global Operations section of the (e)Trial Master File
  • Assume responsibility for other project or trial-related duties as assigned
Qualifications and Experience:

  • Bachelor of Science degree or equivalent University education/degree in life sciences or healthcare
  • 7 years of clinical trial experience with a minimum of 5 years’ experience in managing Phase II and III clinical trials.
  • Experience in executing a wide range of clinical trial activities from study start up to clinical study report.
  • Experience in managing complex trials (e.g., Phase III trials, difficult patient populations, managing outsourced trials)
  • Experience in managing External Service Providers (ESP) including performance assessments and finance management (invoice review, change order management, budget reforecasting etc.).
  • Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical
  • Trial Management Systems (CTMS) systems
  • Experience in managing global teams in a virtual environment
  • Proven track record for delivering clinical trials within time, budget, and quality expectations
  • Strong project management expertise
  • Strong interpersonal, communication (written and verbal) and organizational skills
  • Self-motivated and able to work effectively in a matrix/team environment
  • Excellent knowledge of International Council for Harmonization/Good Clinical Practice (ICH-GCP) including international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia)
  • Fluent in English; fluency in other languages is preferred
  • Advanced computer skills (e.g., Microsoft Office, Word, Excel and Power Point)
  • Available to travel domestically and internationally
  • Relevant working/residency permit or Swiss/EU-Citizenship required
Our Offer:

  • A competitive salary and generous social benefits
  • Senior management support and guidance on career planning
  • International experience
  • Internal training
  • Social and professional networking activities
  • For applicants from abroad we provide relocation support in terms of obtaining work permits, finding accommodation, tax and legal advice and general information on living in Switzerland