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Clinical Trials Manager

Tactile Systems

Minneapolis, Minnesota
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Job Details

Position Summary

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.

Accountabilities & Responsibilities

  • 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, recruitment materials,, and other study related tools
  • Interact with investigative sites through training and ongoing communication to ensure successful execution of the clinical trial
  • Independently conduct clinical trial monitoring including 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
  • Plan investigator 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
  • 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 Tactile Medical general business functions, products, and procedures
  • Assist with data analysis and interpretation of the results
  • Coordinate the development and submission of clinical reports and abstracts/manuscripts
  • Oversee development and management of the clinical database
  • Provide work direction to study team for larger trials with future opportunity to manage Clinical personnel

Education & Experience:

  • BA/BS with 5-9 years of experience in medical device clinical research
  • Minimum 2 years of experience managing clinical trials
  • Strong working knowledge of FDA regulations, GCPs, and current industry practices related to the conduct of clinical trials
  • Experience in database development and post-market research preferred
  • ACRP or SOCRA certification preferred
  • Ability to travel as required (up to 30%)
  • Ability to lift 20-30 pounds

Knowledge & Skills:

  • Proven problem solving and decision making skills
  • Ability to work both independently and in a team-oriented, collaborative environment
  • Skilled in all aspects of a clinical trial including, but not limited to, development of quality documents and study materials, clinical site selection, activation, monitoring, data review, query management, study closure, analysis, and clinical report
  • Comfortable with multiple Electronic Data Capture (EDC) Systems
  • Excellent communication skills (oral and written)

  • Change Agent
  • Influencing
  • Planning
  • Communication
  • Process Management
  • Peer Relationships
  • Problem Solving
  • Attention to Detail

EEO Statement:

It is the policy of Tactile Medical to provide equal opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Tactile Medical will provide reasonable accommodations for qualified individuals with disabilities.

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