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Clinical Project Manager II - Remote Job

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Date: Sep 23, 2021

Location: Valencia, CA, United States, 91355

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

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 work experience
  • Bachelor's Degree 
  • 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 

 

Requisition ID: 505189

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


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