Clinical Trial Manager

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/27/18
5 - 7 years experience
Salary depends on experience
Posted on 03/27/18

Job ID 2018-11228

Summary of Position with General Responsibilities:

The individual in this position will participate on multi-disciplinary project teams to plan and execute successful clinical studies in support of corporate objectives. The Clinical Trial Manager will demonstrate proficiency in all areas of clinical study development and execution, with an ability to build and direct effective multi-disciplinary project teams.


Essential job Functions:

  • Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget
  • Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
  • Interact with investigative sites through training and ongoing communication to ensure successful execution the clinical trial
  • Assist with oversight of clinical trial monitoring including attendance at qualification, initiation, monitoring, and close-out visits as needed
  • Oversee the appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
  • Planinvestigator and coordinator meetings and prepare and present meeting materials
  • Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and Good Clinical Practices
  • Select and manage external vendors/CROs to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
  • Participate on cross-functional core project team to ensure clinical deliverables are aligned with corporate objectives
  • Develop an understanding of competitive landscapes for assigned products and therapeutic areas
  • Demonstrate understanding of Lutonix general business functions, products, and procedures
  • Coordinate the development and submission of clinical reports and abstracts/manuscripts
  • Oversee development and management of clinical database
  • Provide work direction to study team and may manage Clinical personnel


Basic Qualifications:

  • BA/BS
  • 6+ years of experience in the Clinical Research Industry
  • Strong computer skills with a proficiency with MSWindows based applications
  • Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials
  • Excellent communication skills (oral and written)
  • Strong interpersonal and organizational skills and the ability to manage multiple tasks
  • Ability to work independently and provide work direction to others
  • Able to travel 20% on average and up to 40% during peak periods


Additional Desirable Qualifications Skills and Knowledge:

  • 2 + years experience with peripheral vascular devices
  • 2+ years experience in managing clinical research studies
  • Previous experience with EDC systems
  • Device/drug combo technologyexperience
  • Experience managing direct reports preferred
  • Demonstrated ability to work effectively on cross-functional team
  • 2+ years of experience managing personnel is preferred #LI-NL1
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