Clinical Trial Manager - Root, Schweiz - Novocure

Novocure

Geprüftes Unternehmen

Root, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Location:

Root D4, CH, 6039Novocure 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.

For our team in Root, Switzerland we are looking for a

Clinical Trial Manager

As Clinical Trial Manager, you will independently implement and oversee all areas of clinical trial management including, but is not limited to, managing day-to-day activities from start-up to closeout on (multiple) clinical trials and management of vendors such as Contract Research Organizations (CROs) and/or investigative sites.

Your responsibilities:

Implement and successfully conduct clinical trials per Novocure's internal Standard Operating Procedures, Good Clinical Practice regulations as well as applicable country's regulations
Prepare the writing of clinical documents and the study execution plans
Ensure activities comply with the applicable Novocure Quality System requirements
Managing the completion of routine and advanced trial startup, conduct, and closeout activities to industry and corporate standards
Lead TMF review and tracking of CRO
Track key trial activities and milestones
Initiate and coordinate feasibility assessment, potential investigator identification, and site selection
Oversight of studyspecific tools (including communication tools such as newsletters, flyers, etc.)
Responsible for oversight of vendor performance, internal metrics, and communication of trial status within and outside the trial team
Plan, implement and track clinical budgets
Review and approve Vendor invoices, including investigator grants and passthrough costs
Organize and participate in investigational meetings and site training representing assigned clinical trial
Lead the followup of inhouse and onsite sponsored quality audits, comonitoring visits with CRO monitors, as well as, regulatory authority inspections
Train and mentor clinical operations team members such as Jr. CTMs and CTAs

Your profile:

Minimum of 6 years' experience working in different positions in the field of clinical trials; CRAlevel experience is a plus
Minimum of 2 years of experience in leading clinical trials (phases II-III)
Knowledge of regulatory affairs
Familiarity with Medical Device regulations, clinical trials, and ISO
Experience leading Clinical Trial Processes
Experience in global management is a plus
Oncology experience preferred
Experience in the management of CROs and other service providers (including central laboratories)
Working knowledge of ICH/GCP
Fluency in English
Average travel commitment of 2530%, which includes overnight and international travel as needed