Clinical Trial Manager

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

📋 Description

• Manage site operations, monitoring oversight, and activities related to clinical trials to ensure adherence to GCP, regulatory standards, and company SOPs.

• Collaborate closely with cross-functional teams and clinical sites to enhance study execution, site engagement, and operational proficiency across clinical trials.

• Direct site feasibility assessments, selection, initiation, and approval processes for clinical trial sites.

• Create and sustain study-specific operational plans, training resources, and monitoring documentation.

• Supervise site management tasks, including site engagement, regulatory submissions, and monitoring oversight.

• Assess trial progression, patient recruitment, and data quality metrics, implementing actions to achieve study goals.

• Offer guidance and oversight to Clinical Research Associates (CRAs), including the review of trip reports and training assistance.

• Handle protocol and GCP deviations while contributing to the ongoing enhancement of clinical operations processes and procedures.

⛳️ Requirements

• A Bachelor’s degree in life sciences, nursing, or a related discipline.

• Over 2 years of experience in on-site clinical monitoring and a minimum of 2 years as a Clinical Trial Manager in the pharmaceutical or biotechnology sector.

• In-depth knowledge of ICH-GCP, FDA, EMA, and relevant clinical trial regulations.

• Proven experience in managing clinical trial sites, monitoring activities, and maintaining regulatory documentation.

• Competence in using clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office).

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation, provided upfront each year and prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• Comprehensive employer-paid short- and long-term disability coverage.

• 401(k) plan with immediate eligibility and company matching… The company will match 100% of your contributions up to 3% of your base salary for the initial two years of employment, 4% for years 2-3, and up to 5% of your salary from the fourth year onward of continuous employment.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.