Available Positions

Senior Clinical Trials Manager at Pharmaceutical Company in Princeton, New Jersey, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Princeton, New Jersey, United States
  • 10/17/20

Job ID: 63215

Job Description

SUMMARY

The Senior Clinical Trial Manager (Sr. CTM), Clinical Operations role is a “player-coach” position, responsible for oversight and management of company-sponsored clinical trials. The Sr. CTM, Clinical Operations is responsible for the forecasting, management, execution and reporting on clinical trial operations for clinical trials. In addition to clinical trial-related responsibilities, the Sr. CTM, Clinical Operations will also support the Clinical Operations function on process improvement and/or non-project-related initiatives to make operations more efficient and effective. 

 

This individual will be part of the cross-functional Clinical Development department and will provide expertise to multidisciplinary Project Teams in support of Clinical Development plans and company objectives. The position is expected to perform largely autonomously in the execution of assigned clinical trials, but will operate under the guidance of the Sr. Director, Clinical Operations.

 

CORE RESPONSIBILITIES

  • Manage all aspects of clinical trials including: assessing operational feasibility and recommending study execution plan; developing and managing comprehensive study timelines and metrics; participating in selection and management/oversight of external vendors; reviewing vendor reports, budgets, and metrics; support study-specific training to clinical research staff, including CRO, CRAs, Clinical Sites and other contract personnel; planning, executing, and leading study-specific meetings, as needed
  • Ensure internal project team members are aware of their roles and responsibilities as members of the study team in order to streamline internal activities related to study conduct
  • Ensure all clinical trials are executed in compliance with national/international GCP guidelines/regulations and SOPs
  • Participate in the planning of Quality Assurance activities and coordinates resolution of audit findings
  • Ensure audit-ready condition of Clinical Trial Master Files associated with their studies
  • In collaboration with Sr. Director, oversee and manage study budget to ensure study and projects remain with contractual obligations
  • Implement approved clinical trial protocols and operational plans, which are consistent with strategic corporate goals
  • Collaborate with appropriate functions in the selection of CROs and vendors
  • Proactively identify risks to study timelines and budgets and propose risk mitigation strategies/solutions

 

Department specific/Non-essential responsibilities:

 

  • Identify opportunities to optimize/enhance processes and/or systems and support leadership in process improvement/non-project-related initiatives
  • Other duties as assigned with shifting priorities

 

Qualifications

EXPERIENCE AND QUALIFICATIONS

 

Experience / Skills:

  • BA/BS degree or higher, preferably in the life sciences
  • Must have at least 6+ years successfully managing clinical trials and 2+ years managing CROs 
  • Previous experience in leading project operational teams through clinical trial start-up, conduct, data management, and report writing
  • Experience with managing clinical trials, including global trial experience
  • Broad knowledge of drug development processes, in particular those directly related to R&D and clinical operations
  • Experience in writing, reviewing and editing protocols and clinical study reports 
  • A working knowledge of Guidelines and FDA regulations 
  • The ability to exercise judgment and determine appropriate action 
  • Ability to manage deadlines and budgets and a proven ability to provide solutions to a variety of technical problems of moderate scope and complexity
  • Ability to lead multidisciplinary teams and leverage individual skills
  • Strong communication skills to explain complex concepts to management and/or stakeholders
  • Ability to provide solutions and act professionally in an uncertain environment
  • Aptitude to compile, analyze and present data in concise manner
  • Strong active listening skills and ability to articulate and formulate solutions and actions in a clear business language

 

Competencies:

  • Ability to motivate and drive activities within a cross-functional and cross-cultural, global team structure
  • Must be a team player with a positive attitude in the midst of managing and executing shifting priorities
  • Possess a combination of critical thinking, managerial courage and proven effectiveness within complex business environments
  • Ability to drive difficult decisions to conclusion
  • Ability to influence various teams without authority
  • Ability to work in a virtual setting/across time-zones and make effective use of communication tools (Zoom, Team Meetings, WebEx and video conferencing)
  • Ability to listen to all concepts and effectively communicate ideas and data both verbally and in writing in a persuasive and appropriate manner to a broad array of stakeholders
  • Ability to creatively propose solutions in the absence of precedence
  • Self-driven individual able to function with minimal supervision
  • Proficient with MS Office products and other technology tools (e.g., MS Word, PowerPoint, Excel, Project)
  • Travel approximately: ~10-20% to resolve field issues and meet with Service Providers

 

Organizational Relationship/Scope:

  • Reports to: Sr. Director, Clinical Operations

 

Working Conditions:

  • This position can be located in Princeton, NJ or remote-based for the appropriate candidate.
  • Standard office environment.

 

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