Director, Safety Monitoring

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 07, 2020
Closes
Oct 07, 2020
Ref
2584
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for a Director of Safety Monitoring based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for the office location or work remote preference dependent upon position.

Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

Reporting to the Medical Director, the Director of Safety Monitoring will implement Safety Services Group (SSG) activities in collaboration with other members of the SSG. The incumbent will supervise and manage activities of all Safety Monitors, to include utilization and training requirements, and will also be responsible for ensuring coordination of safety monitoring for all clinical projects in conjunction with the assigned Medical Monitor and the project team.

Responsibilities
  • Direct and oversee a team of Safety Monitors to implement CSPG activities and reach objectives
  • Coordinates safety monitoring activities with Project Medical Monitor
    • Reviews safety events
      • Provides first line evaluation of serious adverse events (SAEs)
      • Communicates with site staff regarding reported AEs or SAEs to gather additional information
      • Prepares a summary narrative for each reported SAE suitable for inclusion in DSMB reports, regulatory submissions and final study reports
      • Maintains ongoing database of SAEs and reconciles SAEs in the database as needed
      • Reviews adverse events for the study on a regular basis.
    • Communicates with sponsor, investigator site staff, pharmaceutical and other study partners.
      • Responds to site, sponsor, pharmaceutical partner requests for information regarding safety in clinical trials
      • Participates in Data Safety Monitoring Board (DSMB) or other safety review committee (SRC) meetings as necessary
      • Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report, and periodic safety reports
    • Coordinates with project staff
      • Participates in project team meetings
      • Participate in the planning, preparation, and development of all safety-related sections of protocols, study specific Manual of Operations (MOP), project SOPs, and ancillary documents to ensure project compliance with corporate SOPs
      • Contribute to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SMP)
      • Maintains documentation required by corporate and project SOPs
      • Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities
    • Performs MedDRA and WHO Drug coding, as applicable
    • Other corporate activities including annual SOP reviews, development and teaching EmmesU classes, participation in corporate safety meetings/activities; and other corporate PV activities
    • Other duties as assigned


Experience
  • RN degree, PA degree or bachelor's degree in a scientific discipline with equivalent clinical experience
  • Demonstrated experience with clinical trial data collection and total of 9 years in clinical research with 3-5 years' experience in safety monitoring/pharmacovigilance
  • Demonstrated use of medical terminology and ability to extract information to create a case history.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically and medically sound and understandable way.
  • Excellent oral and written communications skills
  • Ability to work as a team member and function on a cross-functional team
  • W orking knowledge of MedDRA and WHO Drug coding strongly preferred


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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