Senior Clinical Study Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic oversight for the operational planning and execution of intricate programs and individual In Vitro Diagnostics (IVD) clinical studies from initiation to close-out, ensuring compliance with protocols, Good Clinical Practice (GCP), and regulatory standards.

• Supervise site and vendor selection and management activities for clinical trial services, ensuring that contracts, scope of work, and performance metrics align with study goals and Standard Operating Procedures (SOPs).

• Create and implement detailed operational plans for studies, encompassing timelines, budgets, resource allocation, and risk mitigation strategies to guarantee efficient and successful study execution. This includes the development and writing of clinical study protocols, informed consent forms, and other critical study documentation, ensuring scientific rigor and operational viability.

• Establish and sustain effective communication channels with investigators, site personnel, internal stakeholders, and external partners to promote seamless study progression and timely resolution of issues.

• Conduct regular assessments of clinical study data, site monitoring reports, and operational metrics to identify patterns, ensure data integrity, and proactively address any performance or quality concerns.

• The individual will serve as a primary point of contact and actively assist during internal and external audits and regulatory inspections, ensuring timely provision of documentation and addressing any findings or observations.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related discipline with 8+ years of work experience, or a Master’s degree with 6+ years of relevant experience.

• Proven comprehensive knowledge of regulatory standards, study execution, data integrity, strategic and tactical planning, written and verbal communication, and project management principles for clinical studies.

• Experience collaborating with all levels of management and consulting with key internal business stakeholders, demonstrating the ability to influence effectively.

• Direct experience with Immunohistochemistry (IHC) operational workflows.

• Capability to operate in a global environment.

🏝️ Benefits

• Paid time off

• Medical/dental/vision insurance

• 401(k)