Manager, Clinical Safety Committees

1 week ago

Oklahoma City, Oklahoma, United States J&J Family of Companies Full time

Manager, Clinical Safety Committees W

Description

Johnson & Johnson is currently seeking a Manager, Clinical Safety Committees to join our Abiomed Team located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .

Responsibilities:

  • Managerial skills: Effective management, development, including goal settings, performance reviews, and mentoring of direct reports and other Abiomed employees as needed
  • Manage development of study specific committee charters and associated documents
  • Manage work flow and processes for all aspects of CEC adjudication per the CEC Charter, including consistent application of protocol definitions, for applicable studies
  • Review of study specific documents (e.g., protocol, safety management plan etc.) and study data as required
  • Attend CEC meetings and ensure member questions are addressed relative to individual events and surrounding circumstances
  • Support reconciliation of all adverse events for endpoint criteria, completed adjudication, database entries and quality control
  • Collaborate with internal and external stakeholder to implement CEC and DSMB activities to achieve study milestones to ensure study deliverables are met
  • Collaborate with internal stakeholders on execution of DSMB activities (creation of mock tables, data review, hosting meetings, LOR responses)
  • Accountable for the design, authoring, implementation, and execution of applicable standard operating procedures (SOPs)
  • Responsible for audit readiness of CEC and DSMB related activities
  • Oversight of scheduling, training, and contracting of committee members
  • Oversight and management of ARO/CRO when committee activity is outsourced
  • Assist with management of Independent Medical Monitoring activities as applicable
  • Oversee maintenance of committee member documentation and committee activity documentation in the study electronic master file (eTMF)
  • Develops and manages Clinical Trial Committee processes, process improvement and strategies
  • Manages communication with cross-functional teams and external stakeholders regarding clinical trial committee processes, procedures, and outputs
  • Maintains expertise and understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies, and process
  • Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision-making

Qualifications

  • Bachelor's degree in medical sciences, clinical degree
  • Minimum 8 years of experience in medical device/pharma/biotech and medical safety
  • Minimum 4 years managing CECs and DSMBs
  • Minimum 3 years of employee management
  • Ability to work with a minimal amount of supervision
  • Effective analytical and problem-solving skills; willing to develop strong knowledge base in mechanical circulatory devices
  • Excellent written and oral communication skills
  • Must be computer savvy, EDC experience and highly proficient in Microsoft Office: Word, PowerPoint, and Excel (i.e., format documents, presentations, spreadsheet formulas)
  • Travel: May require travels in US, and international travel (10%) of the time

This job posting is anticipated to close on , the company may however extend this time-period.

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $113,000 to $165,000.

The pay range is the anticipated pay range for the position to which you have applied, and that such factors, including but not limited to, internal equity and experience will be considered for any offer. Additional information can be found through the link below. For additional general information on company benefits, please go to: .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

Primary Location NA-US-4887-Danvers

Other Locations NA-United States

Organization ABIOMED Inc.(6942)

Job Function Drug & Product Safety Operations

Req ID: W


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