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Sr. Manager, GCO Study Start Up - Remote Job

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Date: Feb 19, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations:

 

 

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:

Within Global Clinical Operations, our mission is to ignite what’s possible. Our efforts to align clinical site start up work into a Center of Excellence is one of many elements we are pursuing to achieve this mission. Specifically, this Sr. Manager is responsible for leading the activities of the Global Site Start-up Center of Excellence (SSU COE), and conducting activities to inform, connect and advance the company's Global Clinical Organization. Through coordination with enterprise-wide partners leads a team of individuals responsible for clinical trial site start-up activities including the preparation and approval of clinical study agreements (CSA) and clinical site budgets in collaboration with BSC Legal and Payment group and the preparation and collection of the regulatory documents required to activate a clinical study site.  The Sr. Manager will ensure that the team completes these activities ensuring they are carried out consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.   

 

Your responsibilities will include:

  • Providing daily direction to the team to ensure proper site coverage and prioritization of tasks
  • Coordinating service level agreements with Clinical Trial Managers across divisions to ensure consistency and scalability of service
  • Refining and analyzing performance-level metrics at the project, program and departmental level
  • Preparing meaningful and timely updates for divisional Vice Presidents and Directors and other executive management
  • Leading process refinement and enhancement to drive efficiency and improve quality
  • Ensuring that SSU COE are trained to the study-specific training plans
  • Coordinate with leadership and clinical study teams to continually prioritize SSU as new information and/or considerations are introduced to keep pace with the overall service level targets  
  • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission and approval status, etc.
  • Maintain and stay current with divisional leadership to understand their priorities as applicable to the SSU COE
  • Escalate risks and/or initiate outreach to leadership, divisional clinical study leads and/or other stakeholders when appropriate
  • Ensure compliance with appropriate regulatory (ICH/GCP, CA, EC, etc.) and internal SOPs/WI, policies & procedures
  • Identify and support the implementation of technologies or tools to add process efficiency

 

What we’re looking for in you:
Minimum Qualifications

  • Bachelor’s Degree, or an equivalent combination of experience and education
  • 6+ years’ leadership experience in clinical/scientific research and medical device experience
  • Experience working with clinical research centers
  • Experience working with CROs
  • Experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTrial Master Files
  • Experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment
  • Experience and interest in process improvement / enhancement
  • Ability to multi-task and work in a very fast-paced environment 

Preferred Qualifications

  • Experience leading international teams

 

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

 

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.

Requisition ID: 475361

 


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