Clinical Operations

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $59.75 - $70.25 per hour

job description

Clinical Operations

Chat with me now! - https://flashrecruit.com/jobs/301556

Job Title: Clinical Trial Operations Manager III

Job Description

The Clinical Trial Operations Manager (CTOM) is responsible for part of the operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP's, SOPs and standards.

Job Responsibilities

The CTOM supports the Senior Lead CTOM and/or Lead CTOM in the scientific conduct of the study and acts with a critical thinking and problem solving mindset. This role will be involved in the scientific conduct of the study and act under the guidance of the Senior Lead CTOM and/or Lead CTOM to guarantee release of homogeneous high quality data in close collaboration with others Clinical Science Operations (CSO) department representatives (e.g. Medical Operations). This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of products.?

Education and Qualifications

  • Required: Bachelor's degree plus at least 2 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 1 year of clinical research experience).
  • Preferred: Advanced Degree in scientific discipline preferred, equivalent RN

    3 years of experience in pharmaceutical industry, 2+ years clinical research experience and 1+ years of prior management and/or supervisory experience in coordinating vendors, budget management or country management
  • Ability to manage and lead international meetings (e.g. Study Teams)
  • Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team)
  • Good Project coordination skills
  • Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
  • Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan
  • Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication)
  • Experience in the management of vendors for outsourced activities is preferred
  • Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
  • Knowledge of International Standards (e.g. GCP, CDISC, ....), company tools, processes and SOPs
  • Good working knowledge of Microsoft Office
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Chat with me now! - https://flashrecruit.com/jobs/301556

get jobs in your inbox.

sign up
{{returnMsg}}

related jobs

    Clinical Operations

  • location: Bridgewater, NJ
  • job type: Contract
  • salary: $71.84 - $84.52 per hour
  • date posted: 5/7/2018

    Clinical Operations

  • location: Bridgewater, NJ
  • job type: Contract
  • salary: $70 - $82.35 per hour
  • date posted: 6/13/2018

    Quality Assurance

  • location: Bridgewater, NJ
  • job type: Permanent
  • salary: $55,000 - $60,000 per year
  • date posted: 6/6/2018