DSMB Operations Specialist

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Full Time Professional New York, NY, US

7 days ago Requisition

Salary Range: $85,000.00 To $95,000.00 Annually

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.

The DSMB Operations Specialist is responsible for coordinating and managing operational aspects of Data and Safety Monitoring Boards (DSMBs) for clinical trials conducted at the Clinical Trials Center. This includes charter development, meeting logistics, documentation, regulatory compliance, and communication with internal and external stakeholders.

• Manage DSMB meeting logistics including scheduling, participant coordination, agenda preparation, and minute-taking.
• Coordinate the collection and presentation of safety and efficacy data for DSMB review.
• Follow up with DSMB members post-meeting to resolve outstanding issues, action items, or concerns.
• Generate and maintain DSMB charters in collaboration with sponsors and internal stakeholders.
• Ensure proper version control, archiving, and quality checks of DSMB related documents.

• Serve as liaison between DSMB members, sponsors and internal teams.
• Communicate trial-related concerns and updates to DSMB members as needed.

• Support DSMB member training activities and verify documentation.
• Acquire and apply working knowledge of clinical research safety conduct, laws, regulations, and standards.
• Ensure all activities are conducted in accordance with GCP and company SOPs.

• Support internal tracking, monitoring, and auditing of DSMB activities.
• Collaborate with internal quality teams to enhance data quality control processes.
• Operationalize safety quality monitoring activities based on best practices.
• Work closely with DSMB team members and assigned staff to prepare and conduct DSMB meetings.
• Assist in the selection and onboarding of DSMB members, including conflict-of-interest checks.
• Collaborate with other members of the safety team in the conduct of DSMB activities

• Perform other duties as assigned by the Department Head.

• M.D. or D.O. degree, plus 3 years safety/pharmacovigilance experience;
  PhD, Pharm
  
  D, DSc, MSN or other clinical degree, with 5 years clinical, academic or research 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.

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through Transit Chek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year

The hiring range for this position is $85,000 - $95,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

To be considered for this opportunity, please submit your resume.

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