Clinical Safety Specialist

Required Qualifications

• Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies

• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)

• Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)

• Strong interpersonal and communication/presentation (oral and written) skills

• Strong organizational skills, attention to detail, critical thinking and analytical skills

• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects

• Ability to travel up to 10% (or more during peak times)

• Provide Clinical Safety Management support for BDPI clinical studies to enable successful completion of study objectives and deliverables. 

• Ensure quality and compliance for safety-related activities performed for assigned clinical studies.

• Conduct Clinical Safety monitoring activities for assigned clinical studies to proactively identify/review/track reportable safety events, identify safety event trends/signals, issue and address data queries, ensure timely reporting for reportable safety events (e.g., Unanticipated Adverse Device Effects, device deficiencies, etc.), address/escalate safety non-compliance issues, and verify that any corrective actions are implemented.

• Serve as the Clinical Safety expert and resource for BD stakeholders, Investigators, and study site personnel for assigned clinical studies. 

• Develop and maintain strong relationships with investigational site staff, HCP consultants (e.g., Medical Monitors, CEC/DMC members), and cross-functional study teams to support Clinical Safety deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, CRAs), as needed. 

• Develop and manage study-specific tracking reports for Clinical Safety, as needed, to ensure Clinical Safety reporting is completed compliantly and that other Clinical Safety deliverables are completed within study-specific timelines and budgets for assigned clinical studies. Provide regular Clinical Safety status updates to relevant BD and study stakeholders.

• Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that Clinical Safety related study files are current, accurate, complete and audit-ready.

• Develop and/or complete study-specific Clinical Safety Plans, Medical Monitor Approval Forms, Clinical Events Committee (CEC) Charters, Data Monitoring Committee (DMC) Charters, Sponsor Assessment of Event Templates, Potential U(S)ADE/Serious Health Threat Assessment Forms, Preliminary Clinical Safety Threshold Evaluation Forms, Safety Event Narratives, Financial Disclosure Forms, Potential Conflict of Interest Forms, Requests for Clinical Supplier Contract Forms, Study Training Records, Clinical Non-Compliance Escalation Forms and other essential clinical safety-related study documents, as needed.

• Review and provide input on the development of other essential clinical study documents related to Clinical Project Management, Site Management & Monitoring, Clinical Data Management, Clinical Statistics, Clinical Product Management and Clinical Supplier Management.

• Report and escalate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data collection and study performance to BD stakeholders in accordance with established clinical study procedures, regulations and company policies. 

• Manage safety-related interactions, training and invoicing for Medical Monitors, CEC Members, DMC Members and other Clinical Safety vendors.

• Participate in, support and/or lead study-specific meetings including, but not limited to Safety Event Trending Meetings, CEC Adjudication/Meetings, DMC Meetings, safety-related study team meetings, and vendor meetings.

• Provide critical thinking and support for issue escalation related to Clinical Safety. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and create mitigation strategies in collaboration with Clinical Project Management and other leadership.

• Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to Clinical Safety activities.

• Support continuous improvement activities/initiatives and sharing of best practices, including development of Clinical Safety tools and resources.

• Mentor Clinical Safety personnel and conduct evaluations for other Clinical Safety personnel, as needed. Identify performance issues and training opportunities and communicate with Clinical Safety leadership, as needed.