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Clinical Trial Operations Manager IV

Bridgewater, NJRandstad LifeSciences

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Job Title:  Clinical Trial Operations Manager IV

Job Summary

  • Responsible for aspects of clinical trial including key data management activities in compliance with GCP’s, SOPs and standards within established timelines, and budgets.

Job Responsibilities

  • The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data.
  • The CTOM is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning.
  • The CTOM must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders.
  • The CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of products.

Education & Qualifications

  • Bachelor's degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry in clinical trials or clinical-related discipline
  • Demonstrated ability to  to efficiently work with other CTOMs in the same study
  • Experience in managing and leading international meetings (e.g. Study Teams)
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to lead transversal activities
  • Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.)
  • Cross-functional leadership fostering team spirit and team motivation (team work), e.g. study team or transversal project team
  • Display stakeholder management skills (e.g. ability to manage expectations).
  • Strong organizational, project management and presentation skills - including experience with effictive oversight of service providers
  • Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
  • Ability to handle multiple tasks, prioritize his/ her activities and to drive the team accordingly
  •  Ability to coordinate multiples interfaces: Complex studies including several vendors, external non-standard data (e.g. Complex biomarkers, imaging, etc.)
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to work autonomously, to efficiently and effectively provide status reports
  • Capability to routinely perform data management activities and oversight, data review and analysis (clinical & operational) to propose actions and a remediation plan
  • Ability to appropriately delegate responsibilities (e.g., Internally - when several CTOMs involved on a study/ Externally - in case of outsourced activities)
  • Ability to identify and implement synergies
  • Strong English skills (verbal and written if English is the second language) i.e., ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication.
  • Alert on purpose, communicate on issues with proposed action plans.
  • Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
  • Encourage collaboration and communication within and beyond the team
  •  Analyze issues (i.e. context, impact risk)
  • Provide action plans for decision making
  • Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
  • Create buy-in/ support from stakeholders
  • Collaboration with partners
  • Experience in the management of vendors for outsourced activities
  • Ability to effectively interact with scientists and managers within and outside CSO SCP, serving as internal consultant on assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects
  • Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
  • Respond constructively to requests (i.e. either accept or challenge the request, why, when, who & what)
    Act for change
  • Ability to adapt and be flexible to change, managing internal and external challenges & opportunities
  • Creatively challenge the status quo to find new ways of working and proactively propose solutions
  • Readily adapt to new environment, jobs, technologies and processes (e.g. new CTMS, tools)


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


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