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Clinical Project Manager II - Remote Job

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Date: Nov 25, 2020

Location: Valencia, CA, US, 91355

Company: Boston Scientific

Additional Locations: US-CA-Los Angeles; US-CA-Sacramento; US-CA-San Diego; US-CA-San Francisco; US-CA-Valencia; US-MA-Boston; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

About this role: 

Supports PDP Core Teams by maintaining responsibility for Clinical deliverables.  Collaborates with cross functional core team members to ensure Clinical projects/programs are carried out consistently with Corporate and Divisional strategies.  Interfaces with Sr. Clinical Management, Medical Director, Divisional Management as well as with physicians and external contacts.

 

Your responsibilities will include: 

  • Supports Regulatory/Clinical strategies as the Clinical Functional Representative and provides Clinical guidance on PDP project teams.
  • 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 in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
  • Tracks development of 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.
  • Directs forecasting of devices for clinical use.
  • Develops clinical study protocols and reviews/approves supporting documentation.
  • Negotiates contracts and budgets with clinical study sites and manages external vendors.
  • Responsible and accountable for several concurrent clinical studies.
  • Tracks development of 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.
  • Ensures 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 presents study progress and known risks to Clinical leadership.
  • Trains, develops, mentors and supervises clinical staff.
  • Develops and maintains strong relationships with clinical study sites and KOLs.

 

What we're looking for in you: 

Minimum Qualifications

  • 10 years of related experience
  • Bachelor's Degree required 
  • Medical Device Experience 
  • Ability to manage multiple complex projects and lead in a matrix organization
  • Knowledge of Good Clinical Practices (GCP) and FDA regulations governing the conduct of clinical trials
  • Experience with managing multiple concurrent clinical studies and clinical teams

Preferred Qualifications 

  • Master's Degree in science/health related field 
  • Neuromodulation experience 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 470541

 


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