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Clinical Systems & Trial Coordinator Specialist II Job

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Date: Nov 26, 2018

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 Clinical Systems & Trial Coordinator Specialist identifies and executes opportunities for improvement and efficiency of clinical trial processes.  Performs activities related to implementation and maintenance of clinical systems, tools, reports, and procedures in support of efficient trial execution and regulatory requirements. Applies technical skills and problem-solving techniques to drive efficient clinical trial activities.  Performs administrative tasks as part of clinical project processes.  Works with clinical project teams to support the completion of clinical trial documentation processes, budgets, contracts and device management (if applicable).

 

Your responsibilities will include:

  • Completion of Study Master File Index (SMFI).
  • Coordinate all translations.
  • Documentation - Receive and process (upload, assigning of attributes, filing, review and approval of subset of documents in CDC) required regulatory, legal and financial documentation in order to ensure successful study start-up (e.g. site initiation visits, product shipment, start of patient enrolment) and GCP study conduct throughout the study, following WI.  Manage study and site document archives (paper and/or electronic) as required.
  • Receipt of core trial documents from all clinical functions and file in accordance with SMFI.
  • Assembly & distribution of mass communications (MOP, Study Tools, Newsletters, Annual Reports).
  • Reconcile site training files.  Monitor and report project-specific training compliance.
  • Manage site/contact/study information on appropriate tool.
  • Assist in identifying areas for process improvement and establishing effective and efficient processes.
  • Understands detailed project plans for application development projects.
  • Work with business users to define and document detailed business requirements for project requests.
  • Work with the development and quality assurance team members to ensure requirements are complete and understood.
  • Participate in application design and prototype reviews.
  • Assist in the testing and implementation of business applications as needed.
  • Assist with IT support of business applications.
  • Prepare and present reports and status information to management as needed.

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s level degree preferred in related field and/or a combination of education and experience
  • 3+ years related experience
  • 2+ years clinical research experience
  • Clinical trial experience required
  • Clinical systems experience required

Preferred Qualifications

  • Experience working with teams cross-functionally
  • Excellent interpersonal, communication and presentation skills    
  • Ability to organize, execute and manage multiple priorities 

 

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: 439566

 


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