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Senior Clinical Trial Manager Job

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Date: May 3, 2019

Location: Shanghai, 31, CN, 0

Company: Boston Scientific

Purpose

  • Responsible forn++drivingn++the strategy andn++managing then++execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.

Responsibilities

  • Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials.
  • Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
  • Tracksn++development ofn++and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
  • Ensuresn++the project team maintains a continuous state of audit readiness.
  • In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
  • Informs and presentsn++study progress and known risks to Clinical leadership.
  • Recruits, manages and develops Principals, Associates and Specialists. Mentors and coaches all level of Project Management.

Management Requirements

  • Not applicable.

Job Scope and Leveling Guidelines

  • Knowledge: A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.
  • Problem Solving: Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
  • Planning and Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
  • Discretion/Latitude; Supervision Received; Decision Making: Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.
  • Business Relationships and Project Management: Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources. Provides leadership to business units.
  • Impact: Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large of ...

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