Senior Clinical Safety Manager - Remote / Telecommute

Job Description :

Pay Range : $66.89hr - $72.89hr

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 client and site personnel and safety committees on compliant safety reporting and appropriate support documentation.

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 practices.
• Leadership skills and ability to influence change.
• Knowledge of and adherence to the client’s Environmental Health and Safety and Quality guidelines.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Represents the 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 the environment and prevention of pollution under their span of influence / control.

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 years experience of relevant medical / clinical and relevant industry experience Required.
• Experience in internal medicine / cardiology / cardiac surgery Preferred.
• Experience with Medical Device Preferred.
30+ days ago