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Medical Device Clinical Safety Manager

3 months ago

Irvine, United States Ledgent Technology Full time

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

Ideal experience -

    • Research exp at the sponsor level within safety
      • CEC and DSMB vendor management, CEC Charter
    • Cardiovascular device research exp
      • If not cardiovascular, if they have device safety experience working with a sponsor level in this type of role (vascular, neurovascular, etc)
    • Most on her team have an MD degree, otherwise have a medical background (nurse or PhD)
    • Data Analysis - Signal Detection

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

* Ability to manage competing priorities in a fast paced environment

* Represents organization as key medical contact on projects including physicians and clinicians; R&D, quality, RA, etc.

* Must be able to work in and help lead in a team environment

* Medical liaison with external physicians and clinicians

* Provides expert medical input to help provide solutions to difficult technical issues and help drive organizational projects

* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control


Desired Skills and Experience

Safety Assessment, Adverse Events, Adjudication, Safety Data, Regulatory Requirements, Medical Devices, CEC (clinical events classification), Complaint Handling, Data Safety Monitoring Board (DSMB), DMB (Data Monitoring Board, Signal Detection

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.