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Sr Manager, Clinical Safety

Date Posted: 6/19/2024

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Job Description

Medical Device Client is seeking a Clinical Safety Manager for a 6+ mo contract in Irvine, CA!

Duration - 6 Months

Location - Irvine, CA

Max Pay - $75.39

Provide technical expertise on safety assessments of adverse events

Key Responsibilities:

* Conduct Sponsor assessment of adverse events and device deficiencies reported through clinical studies (e.g. assessment of seriousness, relationship to device and procedure, and UADE (Unanticipated Adverse Device Effect) determinations). Determine what additional information is required for comprehensive assessment and adjudication, when required. Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation.

  • Report adverse events and complaints according to regulatory requirements, trial safety processes and procedures. Respond to related questions from regulatory authorities.
  • Draft/Design charters and provide oversight of internal and external CEC and DSMB/DMC process. Perform quality assurance of adjudication results and output
  • Design CEC and DSMB/DMC charters, provide safety/regulatory and medical expertise to Quality Compliance/Complaint Handling on medical aspects of reported complaint information
  • Prepare or review complex event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions. Review and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps.
  • Create clinical risk/benefit analysis documents to meet internal and regulatory requirements. Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports
  • Represent safety in cross-functional and core team meetings. Represent safety in internal and external audits
  • Develop training materials and train site personnel and safety committees on compliant safety reporting and appropriate support documentation.
  • Other incidental duties

Education and Experience:

Other: in Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent, 8 years experience of combined medical/clinical and relevant industry experience Required or

Other: in M.D, DO or equivalent, 5 year's experience of relevant medical/clinical and relevant industry experience Required

Experience in internal medicine/cardiology/cardiac surgery Preferred

Experience with Medical Device Preferred

Additional Skills:

* Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with KOLs and clinical personnel

* Ability to translate complex and technical information to project team management and key leadership

* Recognized as an expert in own area within the organization while applying broad-based technical expertise, and has knowledge of other related disciplines

* Expert knowledge of cardiovascular anatomy, pathology and physiology

* Expert understanding of principles of regulatory requirements and adverse events reporting

* In-depth understanding of corporate/global procedures, standard operating procedures, and writing practice

* Leadership skills and ability to influence change

* Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines

* Strict attention to detail

* Ability to interact professionally with all organizational levels


To apply please email your resume to lfulayter@rothstaffing.com

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Job Snapshot

  • Employee Type:Contractor
  • Location:Irvine, CA
  • Job Type:Biotech, Manufacturing, QA - Quality Control, Research
  • Experience:3-5 years
  • Education:Graduate Degree
  • Date Posted:6/19/2024
  • Contact: Laura Fulayter (949) 620-0287
  • Pay Range: $0.00 - $75.00 Hourly
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Job Reference: JN -062024-370147