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Job Details

Trial Manager

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895169 -P
Closing Date: 25 Dec 16
Type: Contract
Salary (£): On Application
Benefits: Competitive

Job Summary:

The Trial Manager (TM) will be responsible for supporting the operational management (i.e., activities, tasks) and oversight of clinical trials within their assigned countries

Requirements:

Reference Number:          895169 -P

Type of placement:          Contract, 12 months

Location:                         Basel area, Switzerland

 

Purpose:

The Trial Manager (TM) will be responsible for supporting the operational management (i.e., activities, tasks) and oversight of clinical trials within their assigned countries

 

Main Responsibilities:

  • Responsible for supporting the operational management and oversight of clinical trials within assigned countries/regions
  • Work closely with trial team to support trial related activities at the country/site level (site initiations and closure, import/export licenses, trial master file, contracts and invoices)
  • May participate in the selection and training  of external service providers (ESPs)
  • Oversee performance of ESPs to ensure compliance with study protocol and in accordance with scope of work
  • Review ESP invoices to ensure that work is performed in accordance with scope of work
  • Proactively identify and resolve issues with external service providers in a timely and efficient manner
  • Contribute to the development and updating of trial-related risk management and contingency plans, and proactively identify new risks
  • Support submission to Health Authorities and Institutional Review Boards/Ethics Committees
  • May assist in the preparatory activities for Investigator meetings, as well as  participate and present at the meetings
  • Manage and oversee clinical study supplies for assigned country/region.  May oversee IMP importation on clinical study supplies.
  • May facilitate meetings and training sessions (e.g., CRO training) for the specific ESPs
  • Oversee trial progress, assist in resolving issues at a country/region level, identify deficiencies in trial conduct, and define and implement required corrective actions
  • Ensure trial information is kept up-to-date in company’s clinical trial management and documentation systems according to area of responsibility
  • Review and approve invoices (e.g., site payments) for country/region
  • Perform ongoing quality checks/reviews of the (e) Trial Master File and ensure audit readiness in area of responsibility
  • May assist in the preparation for audits/inspections and CAPA implementation
  • Ensure compliance of all activities in accordance with the protocol, ICH/GCP guidelines, local regulations, and company’s Standard Operating Procedures
  • Oversee adherence to legal, regulatory, and ethical standards and guidelines, including Serious Adverse Event reporting

 

Qualifications and Experience:

  • Bachelor of Science degree or equivalent University education/degree in life sciences or healthcare
  • 3 years of demonstrated experience performing clinical trial management activities with at least 1 year of Phase II or Phase III experience
  • Detailed understanding 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)
  • Experience managing External Service Providers (ESPs) including performance assessments and finance management (e.g., invoice review, change order management, budget reforecasting etc.)
  • Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and (CTMS)
  • Strong interpersonal, communication (written and verbal) and organizational skills
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Fluent in English; fluency in other languages is advantageous
  • Experience working in a global matrix environment is preferred
  • Advanced Computer Skills (e.g., Microsoft Office, Word, Excel, and Power point)
  • Self-motivated and able to work effectively in a matrix/team environment
  • Available to travel domestically and internationally

 

 

Apply for this job: Trial Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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