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Senior Clinical Trial Manager ROW

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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. 

As the result of the launch of multiple phase II and III clinical trials we are looking for professionals who would be excited to join a fast-growing, international Clinical Operations team at our Swiss HQ.

To support our team based in Root, Lucerne (Switzerland), we are looking for a

Senior Clinical Trial Manager ROW

You will be responsible for providing strategic leadership and oversight of clinical trials conducted in ROW (currently defined as APAC and South America) to ensure completion on time, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures. You must have a very good understanding of the project status, be able to proactively identify risks and address them appropriately (including escalation to senior management).

Responsibilities

The CTM responsibilities include, but are not limited to the following:
 

Drive execution of the assigned clinical trial(s) on a regional level according to agreed timelines, scope and budget which includes:

  • site identification and selection
  • coordination of submissions to Competent Authorities
  • oversight of the enrollment activities on a global, country and site level
  • ensuring timely data collection, cleaning and lock
  • oversight of the clinical monitoring activities
  • oversight of CROs and other vendors

Focus on quality

  • ensure that clinical trials are conducted in accordance with applicable regulations, ICH GCP, FDA CFR and internal Standard Operating Procedures
  • lead the preparation and follow-up after site, vendor or sponsor audits and inspections
  • be able to work with moderate supervision
  • develop and negotiate site budgets
  • prepare study reports and ensure required tools and tracking databases are kept up to date as required
  • ensure activities comply with the applicable Novocure Quality System requirements.
  • other responsibilities as assigned

Qualifications:

  • Bachelor's degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school
  • Minimum of 10 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
  • Accredited GCP course desirable

Knowledge/Skills:

  • Fluency in English (verbal and written) and excellent communication skills
  • Strong critical thinking and problem solving skills
  • Ability to work well in a team environment
  • Strong critical thinking and problem solving skills
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
  • Excellent organizational and record-keeping skills
  • Ability to maintain excellent working relationships with a broad range of trial staff
  • Flexibility in work hours and readiness to travel abroad on a routine basis
  • Advanced computer literacy

We are looking forward to receiving your application to Patricia Hürsch, Recruiting Manager. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos

 

Address

Novocure
Frau Patricia Hürsch
Recruiting Manager EMEA
D4 Park 6
6039 Root

Website http://www.novocure.com

Root D4 / Root

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