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Location: 

Root D4, CH, 6039

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers. 

 

To manage a global team from Root, Switzerland we are looking for a

 

Associate Director Clinical Trial Management

 

 

The Associate Director, Clinical Trial Management is responsible for independently overseeing all phases of global clinical trial management from initiation through closure, in accordance with applicable Standard Operating Procedures (SOPs), federal and local regulations, and ICH-GCP guidelines.

 

The Associate Director, Clinical Trial Management is responsible for oversight and leadership of the internal cross-functional Project Team conducting a clinical research trial, as well as the management of Contract Research Organizations (CROs) and other vendors, providing oversight of contracted deliverables and parameters. The Associate Director oversees investigative site feasibility, selection and start-up, clinical monitoring and site management, medical monitoring, data management and biostatistics, safety, clinical records, medical writing, supply chain, regulatory submissions, and trial finances.

 

 

Your responsibilities:

 

  • Independently leads assigned clinical trials, Phases I-IV, for investigational devices in accordance with the Clinical Investigational Plan (CIP), applicable Standard Operating Procedures (SOPs), federal and local regulations, ISO standards, and ICH-GCP guidelines.
  • Leads internal and external cross-functional Project Teams, overseeing day-to-day operations, to achieve project objectives in alignment with corporate targets, i.e. enrollment, site activation, and financial performance goals
  • May be assigned as a Global Trial Lead, overseeing regional CTMs on global trials
  • Serves as the primary Sponsor point of escalation for all project/program stakeholders both internally and externally, including for CROs/vendors
  • Manages CROs/vendors, when services are outsourced, providing oversight of contracted deliverables and parameters; may serve as key member of governance or oversight committees
  • Accountable for project financial planning, management, and change control, including vendor contracts and budgets, change orders and amendments, invoice review, budget reconciliations and forecasting
  • Collaborates with the CRO and Functional Leads to develop and evaluate Key Performance Indicators (KPIs) throughout the trial
  • Develops and manages the project timeline, forecasting and tracking milestones
  • Develops or oversees the development and implementation of cross-functional clinical trial documents, including but not limited to: Protocols, ICF Templates, CRFs, study plans, manuals, site-facing materials, and Clinical Study Reports (CSRs)
  • Oversees the development, maintenance, and final transfer of the electronic Trial Master File (eTMF); oversees routine TMF review
  • Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones
  • Oversees internal Project Team training and tracking of training documentation
  • Oversees risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses
  • Oversees protocol deviation management, including tracking and routine review
  • Participates in site feasibility assessment, potential investigator identification, and site selection
  • Oversees clinical monitoring and site management; reviews monitoring visit reports and conducts co-monitoring visits
  • Trains and mentors other Clinical Operations personnel, providing leadership oversight and motivation

 

 

 

Your profile:

 

  • Educated at degree level, with advanced degree highly preferred.
  • At least 10 years’ experience managing clinical trials, preferably from CRA level up to global clinical operations.
  • Experience working hands-on with both phase I/II and phase III studies.
  • Global experience in North America and EU is a prerequisite and additionally experience in APAC would be welcome.
  • Medical Device and oncology experience would be a plus.
  • Strong self-starter, hardworking and independent
  • Mandatory past sponsor experience, with preferably also CRO side experience

 

 

 

 

We are looking forward to receive your application to Sebastian Pal, Talent Partner, through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.

 


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