Novocure
  • 08-Feb-2017 to 09-Apr-2017 (EST)
  • Clinical Operations
  • New York, NY, USA
  • Salary
  • Full Time

Comprehensive benefits plan


The jobholder will implement and oversee all areas of clinical trial management. This includes,

but is not limited to, managing day-to-day activities including trial start-up, conduct, and closeout

activities on (multiple) clinical trials as well as management of vendors such as management of

Contract Research Organizations (CROs) and/or investigative sites. He/she must be selfmotivated,

pro-active and flexible. This position is office based if applicable. This position will

report to the Sr. Global Director Clinical Trial, Director Clinical Operations or Senior Clinical Trial

Manager.

 

*Position can be based out of the following locations: PA, MA, NY, NJ, DE, MD, NC, GA or MD

 

Essential Responsibilities:

Managing the completion of routine trial start-up, conduct, and close-out activities to industry and

corporate standards, with support from a senior member of the clinical operations team. Managing

most aspects of trial operations including vendor performance, internal metrics, and communication of

trial status within and outside the trial team

Ensure that clinical trials are conducted in accordance with the protocol, country regulations, Good

Clinical Practice regulations, and internal Standard Operating Procedures

Ensuring that the progress and completion of trial(s) are in-line with the agreed upon trial

goals/targets such as enrollment, active sites and other milestones, as determined by the

manager

Participate in the evaluation and selection of investigative sites

Follow up and implement clinical site contracts and budgets

Preparation of study specific tools (including communication tools such as newsletters, flyers etc.)

Participates in the set-up and maintenance of study specific trackers including timelines and

budgets to ensure continuous oversight of the study progress

Manage all study-related supplies

Assisting with (or leading, when necessary) the writing of clinical documents such as informed

consents, trial reports, and annual reports

Participate in the preparation and follow-up of in-house and on-site sponsored quality audits, comonitoring

visits with CRO monitors, as well as, regulatory authority inspections

Responsible for the management of trial specific TMF (setup, maintain, archival) including, as/if

appropriate, site regulatory document and legal document tracking and archiving throughout the

duration of the clinical trial in accordance with SOPs, GCP and ICH guidelines

Organize and participate in investigational meetings and site training representing assigned clinical

trial

Preparing and presenting trial specific updates to management and cross functional areas

Ensure activities comply with the applicable Novocure Quality System requirements

Assume any other activities and responsibilities as assigned

Qualifications:

Bachelor's degree in Nursing, Medicine or other Life Sciences or RN degree from an accredited

school

Minimum of 4 year experience working in different positions in the field of clinical trials, including

CRA-level experience (both CRO and industry experience are acceptable)

Familiarity with regulatory affairs in Europe and/ or North America

Version02 02082017 VLS

Familiarity with clinical research in Oncology

Familiarity with Medical Device regulations or clinical trials

Understanding of the European legislation and/ or FDA regulations governing clinical trials and

GCP

Accredited GCP course

Knowledge/Skills:

Fluency in English (verbal and written) and excellent communication skills

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

Ability to work well in a team environment but also independently without significant oversight

Flexibility in work hours and readiness to travel abroad on a routine basis

Advanced computer literacy

 

 

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Novocure
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