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Senior Clinical Trial Manager - United States  

Company managed [?] Still accepting applications

Posted on : 23 May 2017

Project Description

Description:
  • Accountable, under the leadership of the Clinical Trial Head/or Sr. Clinical Trial Head, of all aspects of clinical trial(s).
  • The responsibilities would include: 
    • Provide input to the overall operational trial(s) implementation
    • Manage trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment 
    • function as the primary liaison for internal stakeholders and vendors, as appropriate
    • Lead multidisciplinary departments initiatives
    • provide support for process changes to increase efficiency in study executions

 

Job Responsibilities
  • Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality 
  • Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents; 
  • Manage the evaluation and selection of investigative sites; responsible for feasibility 
  • Select, coordinate and monitor activities of vendors and investigational sites 
  • Review of monitoring reports and conduct co-monitoring visits, as needed 
  • Develop and manage trial(s) timelines, budget and priorities; 
  • Participate in data review and discrepancy resolution 
  • Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress 
  • Generate reports to update management on conduct of trial 
  • Ensure appropriate clinical trial supply plans are implemented and managed 
  • Develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required 
  • Participate in monitoring study safety 
  • Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team 
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work 
  • Assist with CRA and third party vendor training on protocols and practices 
  • Lead the multi-disciplinary trials teams; include the study team meetings 
  • Function as the primary contact for trial(s) between Drug Development and other departments; 
  • Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department 
  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations. 
 



Minimum Requirements
  • BS/BA degree or a relevant degree with strong emphasis on science; 
  • Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials 
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience 
  • Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. 
  • Demonstrated leadership and problem solving skills 
  • Experience in executing a wide range of clinical trial activities (from initiation to clinical study report) 
  • Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment 
  • Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently 
  • Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships