Clinical Trial Manager

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

📋 Description

• Manage site operations, oversee monitoring, and coordinate clinical trial activities.

• Ensure adherence to Good Clinical Practice (GCP), regulatory standards, and company standard operating procedures (SOPs).

• Collaborate with Clinical Operations leaders to facilitate clinical trial execution and monitoring.

• Direct site feasibility assessments, selection processes, initiation, and greenlight procedures.

• Create and uphold study-specific operational plans, training materials, and monitoring documentation.

• Supervise site engagement, regulatory submissions, and monitoring activities.

• Evaluate trial progress, patient recruitment, and data quality metrics, implementing necessary actions to achieve study goals.

• Offer guidance and oversight to Clinical Research Associates (CRAs), including reviewing trip reports and providing training support.

• Manage deviations from protocols and GCP.

• Contribute to the ongoing enhancement of clinical operations processes and procedures.

• Work in collaboration with cross-functional teams and clinical sites.

• Travel domestically and internationally, up to 50%.

⛳️ Requirements

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

• A minimum of 2 years of experience in on-site clinical monitoring.

• At least 2 years of experience as a Clinical Trial Manager in the pharmaceutical or biotechnology sector.

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

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

• Proficient in clinical trial systems and tools, including Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and Microsoft Office.

• Experience in oncology clinical trials or related therapeutic areas is preferred.

• Advanced capability to manage intricate clinical operations processes and foster operational enhancements is preferred.

• Previous experience leading training programs for CRAs and clinical trial sites is preferred.

• Demonstrated ability to enhance quality, efficiency, and milestone achievement in dynamic clinical settings is preferred.

• Experience contributing to process standardization, innovation, and continuous improvement initiatives is preferred.

• Strong skills in presentation, organization, and managing cross-functional stakeholders are preferred.

• Must be authorized to work in the United States without current or future sponsorship.

• Successful completion of background checks, reference checks, and pre-employment drug screening is required; additional screenings may apply for specific roles.

🏝️ 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-funded life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-covered short- and long-term disability insurance.

• 401(k) plan with immediate eligibility and company matching.

• Partially compensated 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.

• Fully remote work option.