MCRA, an IQVIA business is seeking a Director, Clinical Safety to join their team who will be responsible for providing oversight and management of the Safety team members for all clinical aspects of the development and execution of all Clinical Events Committees (CEC), Data Safety Monitoring Boards (DSMB), Medical Monitor Reviews and supporting the requests from our clients and regulatory agencies in relationship to the safety events of the trials. Execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements

Responsibilities and Duties

Be the point of escalation for all Safety related issues that occur.Support all business development activities that involve SafetyProvide clinical expertise to MCRA’s cross functional leadersEnsure that all CEC & DSMB meetings are performed uniformly across the company, according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.Lead and direct project teams to ensure deliverables meet project timelines.Track and report on progress of the meeting preparation and after the conclusion of a meeting.Develop Charter and supporting documents for all meetings.Write safety event narratives to support committee reviewWork in collaboration with the clinical project management team, regulatory team, statistics team, and data management team to ensure the meeting materials are developed in a timely manager and all supporting documents that are available are accessible for the meeting.Support the team in recruiting members to participate in the meetings.Manage independent physician consultants to serve as CEC, DSMB or Medical Monitors on clinical studiesSupport business development team in client/project recruitment efforts.  Provide ongoing process training to study personnel as needed.Develop and maintain positive relationships both internal and external to projects, including clients, team members, and committee members.Maintain knowledge of current GCP, FDA, and other applicable regulations.

Required Knowledge, Skills, and Experience

Education: Bachelor’s degree in a health sciences discipline.

Certification/Licensure: Not applicable.

Experience: Minimum five years of experience in clinical trials management or related field and minimum of three years supporting safety meetings.

Availability: Assume one to three evening(s) per week will be dedicated to participating in the safety meetings. The hours of this role will be flexible due to the demands of client scheduling.

Other:Knowledge of clinical project management, GCPs, and FDA guidelines on safety committees.Demonstrated ability to manage multiple projects simultaneously.Proficiency with MS Office applications.Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring.Demonstrated professional oral and written communications.Ability to read, write, speak and understand English required.

Work environment

Collaborative with a strong team spirit.Interaction with peers, subordinates, and managers.  Entitled to a work environment that is free from harassment.

Physical demands

Prolonged periods sitting at a desk and working on a computer.Must be able to lift up to 15 pounds at times.Visual acuity to read records and documents.

Travel required

Travel (up to 30%) is required for this role pending client requests of having in-person meetings.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $117,400.00 - $218,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.