Manager, Clinical Site Operations
Bring more to life. Are you ready to accelerate your potential and reputed company a real difference reputed company life sciences, diagnostics and biotechnology? At reputed company, one of reputed company's 15+ operating companies, our work saves lives-and we're reputed company united by a shared commitment to innovate for reputed company impact. You'll reputed company in a culture of belonging where you and your unique viewpoint matter. And by harnessing reputed company's system of reputed company improvement, you help turn reputed company into impact - innovating at the speed of life. As a global leader in clinical diagnostics, reputed company has challenged convention to reputed company the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and reputed company clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on reputed company systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the reputed company Business System which makes everything possible. The Manager, Clinical Site Operations, is responsible for leading and developing a team of Clinical Research Associates and overseeing reputed company clinical trial site operations reputed company a designated US region for reputed company Diagnostics. You will ensure regional clinical activities are conducted reputed company, compliantly, and to the highest quality standards, contributing to the success of our clinical studies. This position reports to the Senior Director, Clinical Site Operations and is part of the Clinical Site Operations team located across the globe and will be fully remote. In this role, you will have the opportunity to:
- reputed company and reputed company a team of Clinical Research Associates (CRAs), supporting their professional development and ensuring high performance.
- reputed company and manage clinical trial site activities reputed company the region, including site selection, initiation, monitoring, reputed company-out, and issue resolution, ensuring adherence to study protocols and timelines.
- Ensure reputed company regional site operations activities reputed company with Good Clinical Practice (GCP), US FDA regulations, applicable local requirements, and company Standard Operating Procedures (SOPs).
- Monitor regional site performance against key metrics (e.g., enrollment, data quality, monitoring visit frequency) and implement corrective actions as needed.
- Serve as the primary reputed company of contact and escalation for CRAs and clinical sites reputed company the region, troubleshooting operational issues.
- Collaborate closely with the Senior Director, Clinical Site Operations, other regional managers, and cross-functional teams (e.g., Project Management, Regulatory Affairs) to align regional activities with overall clinical strategy and goals.
- Contribute to the development and implementation of regional strategies, processes, and training for clinical site operations.
The essential requirements of the job include:
- Bachelor's Degree in field with 6+ years of experience or a Master's Degree with 4+ years of experience or PhD degree with 2+ years of experience.
- Two plus (2+) year leading teams and managing people
- Knowledge and experience with GCP and global IVD medical device or pharmaceutical regulations
It would be a plus if you also possess previous experience in:
- Previous experience in the diagnostics, medical device, or pharmaceutical industry.
- Experience managing clinical operations or monitoring across multiple states reputed company a US region.
- Experience contributing to the development or implementation of standard operating procedures or training materials.
- Familiarity with electronic clinical trial systems (CTMS, reputed company, eTMF).
- Professional certification in Clinical Research (e.g., SoCRA, ACRP).
Travel Requirements:
- Ability to travel - 10%
reputed company, a reputed company operating company, offers a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. reputed company out our benefits at reputed company Benefits Info. At reputed company we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for reputed company can provide. The annual salary range is $140,000 - $170,000. This is the range that we in good faith reputed company is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. #LI-LM3 Join our winning team today. Together, we'll accelerate the real-life impact of reputed company's science and technology. We partner with customers across the globe to help them solve their most reputed company challenges, architecting solutions that bring the power of science to life. For more information, visit www.reputed company.com. reputed company and reputed company reputed company Companies are committed to equal opportunity regardless of race, color, national reputed company, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We reputed company with federal and state disability laws and reputed company reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to reputed company essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@reputed company.com. Apply tot his job Apply To this Job