You have an opportunity to play a crucial role in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients. At MDC Associates, that’s our mission, and we need you to help us meet the growing demand for better clinical tools.
As a Clinical Operations Manager you will be responsible for the overall planning of study site interactions and coordinate clinical study activities such as site selection, initiation and monitoring for registration or research studies of in-vitro diagnostics. You’ll be empowered to create and implement strategies and practices that improve the efficiency and effectiveness of clinical operations as a key contributor of the Regulatory and Clinical Affairs team. Join our fast-growing team as we scale up to meet the increasing demand of the medical diagnostics industry.
- Plans overall study site interactions and coordinates clinical study activities
- Develops and implements scalable strategies and practices to improve the efficiency and effectiveness of clinical operations
- Ensures the execution of day-to-day operational aspects of clinical studies in accordance with project goals and objectives, and in compliance with applicable regulations
- Develops and manages comprehensive project timelines and metrics to achieve schedule targets
- Participates in the evaluation, selection, and relationship management of external vendors and study sites, and tracks vendor key performance indicators
- Acts as a key liaison with clinical and scientific groups, societies, and providers
- Organizes and/or hosts study-specific meetings and training events
- Contributes to the selection, training, and evaluation of study personnel
- Serves as a subject matter expert for clinical operation execution, providing guidance around systems, tools, and processes
- Bachelor’s degree in a health care or other scientific discipline or educational equivalent
- 5+ years of relevant clinical study experience in the medical device industry, in-vitro diagnostics preferred
- Fundamental understanding of medical device development, in-vitro diagnostic preferred
- Strong understanding of scientific, ethical, and regulatory guidelines related to clinical research and laboratory medicine (e.g., FDA, CAP, CLIA, ICH-GCP, GMP, GLP, ISO)
- Demonstrated ability to build rapport and effectively lead change efforts
- Demonstrated ability to solve problems and resolve conflicts independently and collaboratively
For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.
By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.
MDC Associates, Inc. is an Equal Opportunity Employer committed to a diverse workforce. MDC Associates, Inc. will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.
25-30% domestic and international travel estimated
Regulatory and Clinical Affairs Manager
In-Office: Beverly, Massachusetts | Remote-Eligible
Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).
Pay and Benefits
MDC Associates, Inc, offers competitive salaries and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone the opportunity and structure to learn and grow.