18 days ago on ctcon.ch

Clinical Trial Manager

CTC Clinical Trial Consulting AG

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 Please refer to JobSuchmaschine in your application

Clinical Trial Manager

Reference Number: 895124 - W
Type of placement: Contract, 12 months
Location: Switzerland, North West


The purpose of this role is to Support the Clinical Trial Leader in execution, oversight and report of clinical trials from vendor selection & site feasibility through study close out. Contributes to the cross-functional Study Management Team (SMT) to support timely delivery of all trial outputs from protocol development to final clinical study report (including archiving of the Trial Master File (TMF) within budget and with high quality standards, in adherence to internal SOPs, GCP and applicable regulatory guidelines.


Main Responsibilities:

  • Contribute to the development & review of study documentation such as the study  protocol, Informed Consent Form (ICF), study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements
  • Contribute to the development of regulatory documents, support the approval of submission packages to Health Authorities and ECs/IRBs and support the Regulatory Department in answering to Health Authority, IRB/IEC and/or DSMB questions/requirements
  • Supports identification and selection of ESPs, including establishment of scope of work and budget negotiation; ensure that related contracts comply with internal SOPs and legal requirements
  • Contribute to the development of specifications for Interactive Response Technology (IRT), Electronic Data Capture (EDC), and any study-related systems. Review ESP specifications in collaboration with SMT and ensure appropriate quality control of deliverables
  • Perform User Acceptance Testing (UAT) and provide feedback to CTL prior to validating study re-related systems
  • Attend or chair regular TC meetings with specific ESP and provide feedback to the CTL
  • Manages ESP’s oversight activities including monitoring and conduct co-monitoring visits to ensure data quality. Perform & document necessary quality checks. Perform ongoing ESP management, performance management and issue resolution
  • Check ESP invoices and ensure appropriate tracking and reconciliation
  • Act as SMT member, attends cross functional SMT meetings and deputizes CTL as needed.
  • Review feasibility results and provide feed-back to the CTL
  • Review forecasting of IMP and study supplies
  • Contribute to the planning & organization of Investigator meeting and CRA training(s), review related material and perform presentation(s) as appropriate.
  • Assist with the set up and maintenance of TMF for studies to ensure proper study documentation is maintained and archived in the TMF
  • Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks to the Clinical Trial Leader and Head of Clinical Operations as appropriate
  • Supports database lock activities oversight, to ensure timely data availability and coordinate study close out with ESPs as neededContribute to the development and follow-up of CAPA
  • Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP and applicable  regulatory guidelines


Qualifications and Experience:

  • Master degree or equivalent university education/degree in life science or healthcare
  • Minimum of 4 years relevant experience in clinical development and clinical trial management, field monitoring experience is highly desired
  • Experience in managing international complex studies (e.g., large studies, specific patient populations, management of several external service providers)
  • Experience in selecting and managing external service providers
  • Thorough understanding of the drug development process
  • Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations
  • Solid experience in project management (including risk management and contingency planning)
  • Experience in executing a wide range of clinical trial activities across Phase I to Phase  IV studies (from initiation to clinical study report)
  • Good understanding of clinical trial budget
  • Strong written and verbal communication and presentation skills
  • Fluent in English (additional languages advantageous)
  • Solid leadership skills, experience in working in global cross-functional (matrix) and multicultural teams
  • Pro-active and problem-solving attitude, strong prioritization skills
  • Ability and willingness to travel internationally