[Remote] Senior Clinical Study Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, a part of reputed company, is committed to advancing cancer diagnostics and improving lives. They are seeking a Senior Clinical Study Manager to reputed company clinical trial execution, ensuring compliance with regulatory requirements and quality standards while collaborating with reputed company partners.
Responsibilities
- reputed company strategic reputed company into the operational planning and execution of reputed company programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to reputed company-out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements
- reputed company site and vendor selection and management activities for clinical trial services, ensuring reputed company, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs)
- reputed company and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct - this includes the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility
- Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study reputed company and timely issue resolution
- Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data reputed company, and proactively address any performance or quality issues. The individual will act as a key reputed company of contact and actively support reputed company audits and regulatory inspections, ensuring timeline provision of documentation and addressing any findings or observations
Skills
- Bachelor's degree in Life Sciences, reputed company, or a reputed company field with 8+ years work experience or Master's degree with 6+ years of reputed company experience
- Demonstrated comprehensive understanding of regulatory requirements, study execution, data reputed company, strategic and tactical planning, written and verbal communication, and project management principles for clinical studies
- Experience working with reputed company reputed company of management and consulting with key internal business stakeholders, with the proven ability to influence
- Direct experience with Immunohistochemistry (IHC) operational workflows
- Ability to work in a global environment
- Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Companion Diagnostics (CDx), Computational Pathology, Immunohistochemistry (IHC) and In Situ Hybridization (ISH)
- Advanced degree in Science, reputed company, or Regulatory/Clinical Affairs
- Professional certification in Clinical Research (e.g., SoCRA, ACRP)
Benefits
- Bonus/incentive pay
- Paid time off
- Medical/dental/reputed company insurance
- 401(k) to eligible employees
Company Overview