C. R. Bard, Inc.

Clinical Safety Manager

1 month ago
Industry / Category
Clinical Safety Manager
Job ID
2017-9893
Career Level
management
Division
New Hope, MN/Lutonix
Relocation
No
US-MN-New Hope

Summary of Position with General Responsibilities

The Clinical Safety Manager manages and coordinates clinical safety team activities.

Essential Job Functions

  • Oversee, process/review/evaluate, and track adverse events
  • Manage timelines and deliverables for safety team/Clinical Safety Specialists
  • Coordinate safety-related regulatory reporting to global health authorities; manage the interaction between Clinical Safety Specialists with Regulatory Affairs and Clinical Operations to ensure timely reporting of AEs, SAEs and UADE’s, including expedited and safety input into the annual reporting and other documents as needed
  • Manage and oversee the overall process for additional safety-related tasks (aggregate trend review and signal detection)
  • Ensure consistency and regulatory compliance in adverse event definitions, adjudications and coding across all clinical programs
  • Train internal and external contacts on safety-related matters
  • Participate/assist in identifying and engaging academic based medical experts for participation on CEC panels, or working with CROs who oversee this function, as applicable
  • Responsible for the development and maintenance of all technical systems utilized in the conduct of clinical event identification, management and adjudication as well as systems used to manage and document all serious adverse events (SAEs).
  • Oversee the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.

Basic Qualifications

  • RN or equivalent healthcare degree at the bachelor’s degree or greater
  • At least 8 years of clinical research safety experience, including clinical safety events management
  • 3+ years of experience managing personnel is preferred
  • Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11, ICH-GCP, other relevant Guidance documents (ICH, FDA, EMA etc.).

Additional Desirable Qualifications Skills and Knowledge

  • Experience in cardiovascular and/or peripheral vascular field
  • Prior project management experience is preferred
  • Proven facilitation skills and the ability to arrive at consensus among competing stakeholders. Must be a leader but still a team player
  • Familiarity with multiple EDC systems
  • Knowledge and working familiarity of MedRA coding and safety management systems (eg. AERS, ARGUS)

Physical Demands

While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers.  The employee frequently is required to see, talk and hear.  The employee is occasionally required to bend, lift, reach or stoop.  Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.  Upon request, the company may make reasonable accommodations. 

 

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment.  Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

 

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