Clinical Trial Manager

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

📋 Description

• Independently oversee all operational elements of designated Phase II–III global clinical trials from initiation to closeout.

• Ensure compliance with study protocols, regulatory obligations, and ethical standards.

• Supervise CROs and vendors in alignment with study objectives, regulatory criteria, and timelines.

• Create and uphold operational, monitoring, communication, and risk-management plans specific to each study.

• Evaluate monitoring visit reports and guarantee the quality control of the Trial Master File.

• Manage study documentation and operational trackers for oversight by the Sponsor.

• Execute strategies for patient recruitment and retention in collaboration with sites and CROs.

• Collaborate with legal and finance departments regarding study budgets, insurance adequacy, privacy and data protection protocols, and contracts.

• Recognize operational risks and develop mitigation and contingency strategies.

• Assist in clinical data analysis, troubleshooting, interpretation, reporting, and communication with stakeholders.

• Keep abreast of industry advancements, regulatory updates, and clinical research practices.

• Establish connections with cross-functional teams, CROs, vendors, and investigator sites.

• Engage with sites and stakeholders on sensitive health matters while ensuring the safety and dignity of participants.

⛳️ Requirements

• Bachelor’s Degree in life sciences, pharmacology, or a related field.

• 5 years of hands-on experience in clinical trial management within the pharmaceutical, biotechnology, or CRO sectors.

• Experience in clinical trial management within an industry sponsor environment.

• Proficiency in configuring, implementing, and managing electronic patient-reported outcomes (eCOA) systems, including compliance verification and data quality supervision.

• Solid understanding of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements related to clinical research.

• Familiarity with clinical trial regulatory filing requirements in major regions (US, EU, UK, etc.).

• Willingness to travel up to 20% of the time as necessary.

• Legal authorization to work in the U.S. is mandatory.

• Must not require sponsorship for employment visa.

• Experience in studies related to women’s health, pain, immunology, and/or dermatology is advantageous.

• An advanced degree (MSc., Ph.D., PharmD, MD) is preferred but not mandatory.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• Unlimited vacation.

• Parental leave.

• Employee assistance program.

• Voluntary life and disability insurance.

• Annual bonus potential.

• 401(k) with a generous company match.

• Equity.

• Home-office remote work arrangement.