Senior Manager, CEC & Safety Operations

at  Cardiovascular Research Foundation

SUMMARY

The incumbent in this position creates and actively manages a positive, high performance and efficient work environment. The incumbent guarantees high integrity clinical safety data for study sponsors and actively works with other departmental staff to identify and implement new efficiencies and technologies for clinical safety. Responsible for development and implementation of all safety related functions to include member related communications, charter development, other meeting preparatory activities, as well as follow up action items.
The incumbent functions as a Safety Manager to review clinical protocols, monitoring the clinical data for completeness, accuracy, and for protocol and regulatory compliance and as a main contact for safety start up activities and day-to-day operations related to the safety services contracted for the assigned studies. Regularly engages with the project manager, faculty members, biostatistical team members to review and ensure that the data for presentation at each Committee meeting is as specified in the Charter. Additionally, engages with members of the Committees communicating regular updates on trials as well as identifying and escalating potential concerns to the members.

QUALIFICATIONS

• M.D. or D.O. degree, plus 3 years safety/pharmacovigilance experience; PhD, PharmD, DSc, MSN or other clinical degree, with 5 years safety/pharmacovigilance experience; 2 years working with DSMB activities preferred.
• Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with Biometrics & Data Management (BDM), Clinical trial Affairs (CTA), Project Management (PM) and other team members.
• Experience in SOPs, clinical documents and templates, required.
• Ability to multi-task and interface with team members who are working under deadlines. Ability to set priorities and excellent organizational planning, project management and time management skills.
• Ability to lead teams and manage projects through non-reporting co-worker influence required.
• Ability to analyze clinical information, data and statistics, as well as perform triage relating to complex information synthesized from multiple sources.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Supports for all project management responsibilities for the Data Safety Monitoring Board (DSMB) activities to include coordination of meeting schedules, participants, preparation of minutes and coordination of data to be presented at the meetings; working closely with the statisticians and programmers as needed.
• Supports the processes for maintaining the CEC and DSMB Charters, managing and communicating with sponsors and members on an as needed basis.
• Supports the communication with CEC and DSMB members on an ongoing basis regarding any potential trial related concerns and following-up with members after the meeting to resolve any outstanding issues or concerns
• Supports that CEC and DSMB members are trained on each iteration of the protocol and charters and documenting the training appropriately
• Works with the CEC and DSMB services assigned staff to prepare and conduct the CEC meetings
• Initiating and managing all committee related requests, escalating and establishing appropriate timelines for completion.
• Supports the development and maintenance of safety infrastructure such as the drafting and/or reviewing of SOPs, guidelines, checklists and work instructions.
• Serves as a liaison between the different bodies involved in the safety process, i.e. between internal and external management teams, CEC and DSMB members, Contract Research Organizations (CRO), Investigators, Clinical Trial Teams and vendors.
• Demonstrates working knowledge of and coaches others in the appropriate application of clinical research safety conduct, laws, regulations, and standards, and compliance with company’s applicable SOPs.
• Conducts all job duties within context of Good Clinical Practice (GCP) and according to company SOPs and guidelines.
• Participates in the preparation and completion of critical clinical trial study documents with regards to safety and perform final editing/proofing prior to publishing (i.e. Charters, Adjudication Forms, others as required).
• Provides input to study teams during protocol development on clinical trial safety monitoring and reporting strategies.
• Provides safety training to staff as needed to ensure complete and accurate reporting of clinical data; oversee monitoring of clinical safety and adjudicated data for completeness, accuracy and regulatory reporting requirements.
• Supports the internal monitoring and auditing of all safety activities, working closely with our internal quality colleagues to enhance data quality control processes; operationalizes safety quality monitoring activities based on best practices.
• May serve as the clinical safety representative or assign designee in working with Food and Drug Administration, including 510(k), Pre-Market Approval (PMA) submissions, Investigational New Drug (IND), Investigational Device Exemption (IDE), all supplements/amendments and responses to FDA questions, and preparation at FDA advisory panel, or any external/internal auditing group.
• Responsible for the development and review of corrective action plans as requested on internal/external audits and implements plans as required.
• Additional duties as assigned.