Safety Trial Manager - Marlborough, MA – Marlborough

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Safety Trial Manager – Safety Trial Operations – Marlborough, MA

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. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce. ~cb

Safety Trial Manager

General Summary:
Provides regional and/or global leadership for the management of the safety monitoring process for particular clinical trials. Assists project team in the design and execution of high quality clinical studies to ensure safety and effectiveness of BSC products. Works under the direction of management on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Interfaces with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO’s.



Duties and Responsibilities:

• Responsible for the management of dynamic safety processes by tracking adverse events, monitoring timelines for event processing, reviewing safety data at regular intervals, and monitoring adjudication results by the Clinical Events Committee (CEC).
  
• Assists in the management of the adjudication process and interacts with core labs
  
• Assists in the development and management of safety trial budgets and resource planning.
  
• Contributes to CRF and protocol design as well as database validation.
  
• Works closely with Safety Trial Operations management to facilitate accurate and timely adverse event processing and reporting and with the Medical Research Associates (MRA) as they compose the narratives for individual adverse events.
  
• Interfaces with project team members and investigators to ensure a timely and precise safety reporting process for the therapeutic program which they support.
  
• May be accountable for one or more concurrent clinical studies.
  
• May train and mentor Safety Trial Operations staff on safety processes.
  
• Participates in and assists in the development and approval of global safety strategies in collaboration with Clinical Sciences management.
  
• Reviews protocols for projects before submission for approval.
  
• Reviews instructions for use for investigational devices.
  
• Attends investigator and coordinator meetings representing the Safety group.
  
• Provides oversight of safety concerns and/or adverse events to ensure they are identified and appropriate responses to such concerns are developed and executed.
  
• Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies.
  
• Participates in the dissemination of safety information to the clinical team members and extended core team members, as appropriate.
  
• Provides clinical support in working with Food and Drug Administration, including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.
  
• Assists in developing and maintaining Safety Trial Operations infrastructure such as the drafting and/or reviewing of SOPs, Guidelines and Work Instructions.
  
• Assists in the development and review of corrective action plans as requested on internal/external audits and implements plans as required
  
• Demonstrates working knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.
  
  
  Minimum Education & Experience:
  Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 5+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials preferred
  
  
  Working Conditions:
  General office environment, with the potential for up to approximately 30% trav
  
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