Researcher, Prin Clin - 100211 - Marlborough, MA - 0300 – Marlborough

Principal CRA – Marlborough, MA

Delivering on the promise of medical innovation begins at Boston Scientific!

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.

We have an exciting opportunity for a Principal Clinical Research professional to join our dynamic team!

General Summary:
Employees at this level fully demonstrate the critical competencies required for the job track, are proven experts in one or more therapeutic areas and are relied on to lead highly complex projects. Principal is the level where an employee's career may stabilize for many years and could even continue until retirement. These employees provide therapeutic expertise and mentor project team members.

Duties and Responsibilities:
?Works with the site selection committee to select appropriate investigative sites with therapeutic experience
?Assists project manager in the set up of Trial Master File
?Actively establishes relationships with investigative sites
?Address non compliance issues at investigative site and develop CAPA if necessary and mentor Junior staff
?Develops project plan
?Execute in agreement with CPP
?Develop and Maintain Relationships
?Prepare and Maintain Clinical trial Budget
?Leads clinical team
?Analyzes metrics data and institutes process improvements to internal and external clinical customers’ reviews for risk management
?Reviews background reports for protocols and study plans for all studies in therapeutic area. Summarizes medical publications and past study summaries for complex next generation projects
?Delivers high quality clinical input to core teams
?Write protocols for less complex studies under guidance of Sr. Project Manager
?Utilize clinical knowledge to assess and improve clinical processes within department
?Mentors CTC/CRA1/CRA2/Sr. CRA and new employees
?Behaves as a role model
?Guides the development of new employees and junior staff
?Promotes teamwork
?Inspires others
?Train all therapeutic area staff
?Train sites on therapeutic subject matter and protocol interpretation
?Site CAPA process and re-training
?Lead more complex studies
?Participates in start-up activities
?Reviews documents
?Active as core team member
?Executes corrective action plans
?Reports complaints
?Identifies need for corrective action
?Ensures up to date training




Minimum Education & Experience:
Education: Bachelors Degree in Science or Healthcare Related Field, Masters preferred.
Professional Experience Years: 7+ years experience in clinical/scientific research, nursing or medical devices/pharmaceutical clinical trials; 3+ years experience in a specific BSC therapeutic area.

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