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Fellow, Safety Program Job

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Date: Jan 10, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)

 

 

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:

The Safety Program Fellow position provides vendor oversight and safety expertise using leadership skills, safety consulting, and mentoring.  Ensures oversight of adverse event reporting and safety deliverables for investigational and marketed products.  Interfaces with other departments, medical directors, senior Clinical management, senior functional management, and acts as BSC representative with CROs.

 

Your responsibilities will include:

  • Vendor oversight: Manage vendor relationship and performance. Ensure oversight of study specific activities carried out by vendors. Set clear performance expectations for the vendor. Review vendor performance metrics and take appropriate action to address issues. Resolve, escalate and document issues. Develop and improve methods of vendor management to ensure successful partnership.
  • Projects: Understand and provide input to the project budget units. Provide projection of units for the specific tasks the vendors will perform.
  • Consulting: Working with the vendor, provide data management expertise and support to study teams
  • Mentoring: provide work direction, guidance, mentoring, influence to vendor’s staff
  • Author study specific CEC/IMR Charter and manage adjudication committees
  • Provide safety-related input to study documents/processes as requested (eg: protocol, CRF design, etc.).
  • Interfaces as Subject Matter Expert and acts as coach and mentor with vendors performing functional tasks.
  • Responsible to determine, implement and execute vendor oversight activities for outsourced functional tasks.
  • May lead initiatives that improve efficiencies of functional processes.

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s level degree required in Biological Sciences/health related fields.   
  • 8+ years minimum experience in the primary role of managing safety within clinical studies
  • CRO oversight experience, minimum 2 years

Preferred Qualifications

  • Working knowledge of ARGUS and Medidata Safety System
  • Experience managing budgets and timeline
  • Excellent communication and collaboration skills; works well with multiple stakeholders
  • Has a solid understanding of functional specialty and industry practices, techniques and standards
  • Identifies opportunities for improvement or efficiency of technical processes; develops and applies creative/technical ideas to projects
  • Independently determines and develops approaches to solutions
  • Adapts to multiple demands and adapts to changes in business requirements, shifting priorities and ambiguities
  • Excellent organization and project management skills

 

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.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 440544

 


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