Clinical Research Manager

The Clinical Research Manager oversees the planning coordination execution and compliance of clinical research studies. This role ensures that all trials and research activities adhere to regulatory standards Good Clinical Practice (GCP) guidelines and organizational protocols. The Clinical Research Manager leads study teams manages timelines and budgets and ensures data integrity and participant safety in a fully remote environment.

This position is strictly limited to candidates who currently reside in the United States and are legally authorized to work in the U.S. Applications from individuals residing outside the United States will be rejected.

Key Responsibilities

• Plan initiate and manage clinical research studies and trials

• Ensure compliance with FDA regulations IRB requirements and GCP standards

• Oversee study protocols timelines budgets and deliverables

• Coordinate with investigators sponsors vendors and cross-functional teams

• Monitor study progress and performance metrics

• Manage clinical trial documentation and regulatory submissions

• Ensure data quality accuracy and integrity

• Lead study team meetings and provide status updates to leadership

• Identify and mitigate risks related to clinical research operations

• Support audit preparation and regulatory inspections

Required Qualifications

• Bachelors degree in Life Sciences Nursing Public Health Clinical Research or related field (Masters preferred)

• 58 years of experience in clinical research or clinical trial management

• Strong knowledge of FDA regulations and Good Clinical Practice (GCP) guidelines

• Experience managing clinical study timelines and budgets

• Excellent organizational and leadership skills

• Strong analytical and problem-solving abilities

• Experience working with electronic data capture (EDC) systems

• Ability to work independently in a remote environment

Preferred Qualifications

• Clinical Research Coordinator (CRC) Clinical Research Associate (CRA) or related certification

• Experience in pharmaceutical biotech or medical device industries

• Familiarity with regulatory submissions and IRB processes

• Experience managing multi-site or global clinical trials

• Project management certification (e.g. PMP)

Compensation

• Annual Salary Range: $105000 $140000 USD based on experience therapeutic area expertise and study complexity

• Performance-based bonuses may apply

Benefits

• Comprehensive medical dental and vision insurance

• 401(k) retirement plan with employer matching

• Paid time off paid holidays and sick leave

• Life short-term and long-term disability insurance

• Flexible remote work arrangement

• Professional development and certification reimbursement

• Employee wellness and assistance programs

Work Authorization & Residency Requirement

• Must be legally authorized to work in the United States

• Must currently reside within the United States

• Applications from candidates outside the U.S. will not be considered