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Clinical Project Specialist - Endoscopy Job

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Date: Jan 11, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough

 

 

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.

 

*Role will start remote - over time ideally looking for someone who can work in the Marlborough, MA office

 

About this role:

The Clinical Project Specialist supports Clinical Project Management in the areas of product development and commercialization through the execution of global Clinical Trials. The Clinical Project Specialist has knowledge of Clinical Project Processes and can execute trial related activities with or without guidance as necessary. The Clinical Project Specialist is familiar with external regulations, internal Clinical SOPs, has knowledge of GCPs and understands the Clinical Study Protocol.

 

Your responsibilities include:

  • Supports the project team in the planning, execution and management of operational aspects of clinical trials
  • With supervision executes clinical studies in accordance with the project plans, budget and resource allocations following applicable regulatory and standard operating procedures
  • In collaboration with the project team, contributes to all internal and external project materials associated with a clinical trial (e.g. protocol, ICF, CRFs, IB, study plans, Study Master File, CSAs, Regulatory submissions)
  • Participates in site start up or close out activities including conducting site visits in partnership with monitors and clinical project manager
  • Manages clinical sites provides daily support and oversight, serves as liaison between site staff and Sponsor, as well as partners with monitors and site staff to identify and resolve compliance issues; Escalates site questions/ needs or compliance issues appropriately to senior staff
  • With supervision, ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan
  • Conducts monitoring activities if assigned as a monitor to the study
  • Attends and/or holds Clinical Project Meetings and manages meeting minutes
  • Regularly reports on study and site progress to project management
  • Provides support with literature search and analysis, and abstracts and manuscripts
  • Supports a continuous state of audit readiness in all aspects of the job
  • Travel up to 40%.
    • Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

 

What we re looking for:

Minimum Qualifications

  • Bachelor s degree in Science or Healthcare Related Field 
  • 2+ years related clinical research experience (within a CRO or other industry experience)
  • Experience working collaboratively with internal cross-functional team

Preferred Qualifications

  • Clinical trial operations experience preferred (ex: Site Management, Monitoring, Data Management, and/or Safety)
  • Comfortable interacting with health care professionals
  • Comfortable reviewing and summarizing scientific literature and data
  • Ability to respond flexibly and positively under conditions of uncertainty or change
  • Strong verbal, analytical and written communication skills
  • Demonstrated problem-solving 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.

 

Requisition ID: 473381

 


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