Director, Clinical Safety
Washington, District of Columbia
Clinical Affairs – Clinical Safety /
Full-time /
Remote
MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
Overview
Provide 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 Safety
- Provide clinical expertise to MCRA’s cross functional leaders
- Ensure 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 review
- Work 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 studies
- Support 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.
Qualifications
- 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.
- 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.
Other:
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, an IQVIA business, 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.
