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Clinical Research Manager, Oncology

TFS
Durham, NC
  • Expired: September 21, 2022. Applications are no longer accepted.

TFS HealthScience is excited to be expanding our Oncology team and looking for an experienced, highly motivated Clinical Research Manager (CRM) who shares our vision of providing clinical research excellence. Our Oncology team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our core values of Trust, Quality, Flexibility and Passion are what makes TFS the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.

TFS HealthScience is looking for a Clinical Research Manager (CRM) based in the United States. We look forward to receiving your application.

Key Responsibilities:

  • Responsible for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
  • Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
  • Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
  • Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
  • Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
  • Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
  • Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.


Requirements

  • Degree in clinical, science or health related field
  • Pervious TA experience in Oncology
  • 5+ years of clinical research experience, as CRA including relevant on-site monitoring experience.
  • 2+ years of LCRA experience
  • Able to work in a fast paced environment with changing priorities
  • Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
  • Possess the understanding of Good Clinical Practice regulations, ICH guidelines
  • Ability to work independently as well as in a team matrix organization and multiple projects


Benefits

What can we offer you?

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. US benefits include:
  • Competitive salary & benefits package
  • Excellent career progression opportunities
  • Great corporate culture and work life balance

TFS

Address

Durham, NC
27701 USA

Industry

Healthcare

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