CRM

A large medical device company is seeking a Clinical Research Manager to support the planning, execution, and oversight of global clinical studies. This individual will be responsible for managing clinical trial activities to support the development, regulatory approval, and commercialization of innovative cardiac ablation technologies and electrophysiology products.
The ideal candidate will have a minimum of 3 years of experience managing clinical trials within the medical device, biotechnology, pharmaceutical, or healthcare industry and possess a thorough understanding of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and global clinical research requirements.
Key Responsibilities

Lead the day-to-day management of clinical studies for electrophysiology medical devices from study startup through closeout.
Develop and maintain study timelines, budgets, risk mitigation plans, and project tracking tools.
Collaborate with cross-functional teams including Clinical Affairs, Regulatory Affairs, Quality, R&D, Biostatistics, Data Management, and Medical Affairs.
Manage relationships with clinical investigators, research sites, contract research organizations (CROs), and external vendors.
Monitor study progress, enrollment metrics, protocol compliance, and data quality.
Ensure clinical studies are conducted in compliance with:
FDA regulations (21 CFR Parts 11, 50, 54, 56, 812)
ICH-GCP Guidelines
ISO 14155
Company SOPs and regulatory requirements

Key responsibilities:
Review and contribute to study protocols, informed consent forms, case report forms, monitoring plans, and clinical study reports.
Support adverse event reporting and clinical safety surveillance activities.
Oversee clinical trial documentation including Trial Master File (TMF) management and inspection readiness activities.
Participate in regulatory submissions, audits, and inspections.
Analyze study performance metrics and provide status reports to senior leadership.
Support publications, abstracts, investigator meetings, and scientific presentations related to clinical studies.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, Public Health, or a related scientific field.
Minimum 3 years of experience independently managing clinical trials in the medical device, pharmaceutical, or biotechnology industry.
Experience overseeing multicenter clinical studies.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.