Clinical Trials Manager

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

📋 Description

• Plan and oversee the operational execution of biomarker clinical trials and IVD kit clinical performance studies from protocol development to database lock and clinical study report.

• Provide operational insights into protocol design, sample handling workflows, and statistical planning.

• Contribute to and review protocols, informed consent forms, CRFs/eCRFs, monitoring plans, budgets, and timelines.

• Lead the feasibility assessment, selection, and qualification of study sites.

• Manage clinical trial agreements, site budgets, and submissions to IRBs/ethics boards.

• Plan and supervise studies from a GCP perspective, which includes project management, risk response, and site management plans.

• Oversee CROs and vendors, managing scope, deliverables, performance, and invoices.

• Supervise site monitoring and address issues and protocol deviations.

• Monitor enrollment, milestones, budgets, and risks; implement mitigation strategies.

• Own study budgets, including forecasting, accrual tracking, and change-order management.

• Lead financial oversight and negotiation of contracts with CROs and vendors.

• Ensure data quality through data review, query resolution, and database lock procedures.

• Maintain an audit-ready Trial Master File and manage deviations and CAPAs.

• Establish and lead CRO governance meetings, monitoring KPIs, quality metrics, and contractual obligations.

• Drive escalation pathways and corrective actions for any performance issues from CROs.

• Ensure compliance with ICH-GCP, FDA regulations, ISO 20916, and company SOPs.

• Support FDA interactions and submissions, including Pre-Submissions/Q-Subs, IDE, 510(k), De Novo, and PMA.

• Enhance clinical operations SOPs and processes.

• Implement risk-based monitoring strategies and plans for quality oversight.

• Conduct risk assessments and document as well as execute mitigation strategies.

• Collaborate with QA on audits and inspections, leading operational readiness initiatives.

• Serve as the primary operational contact for investigators, site staff, CROs, and vendors.

• Collaborate with medical affairs, regulatory affairs, and quality teams.

• Provide management with updates on study status, metrics, and risk assessments.

⛳️ Requirements

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

• 6+ years of clinical research experience in the diagnostics, medical device, biotech, or pharmaceutical sectors.

• Independent management of multi-site clinical studies.

• Strong understanding of ICH-GCP and FDA regulations pertinent to IVD and medical device clinical studies, including 21 CFR Parts 50, 56, 809, and 812.

• Working knowledge and competencies in ISO 20916.

• Working knowledge and competencies in ISO 14155.

• Familiarity with HIPAA regulations.

• Proven skills in clinical project management, including planning, budgeting, risk management, and execution of multi-site studies.

• Experience in managing CROs and vendors, including contract and budget negotiations.

• Proficient in CTMS, EDC, eTMF systems, and MS Office applications.

• Excellent written and verbal communication skills.

• Ability to work autonomously and collaborate effectively within a remote, international team.

• Must be based in the United States.

• Experience in biomarker studies is preferred.

• Background in oncology or urology is a plus.

• Experience with IVD kit clinical performance studies related to FDA submissions is preferred.

• Clinical research certification such as ACRP CCRA/CCRC or SOCRA CCRP is advantageous.

🏝️ Benefits

• Remote work arrangement.

• Willingness to travel to clinical sites and meetings as needed (approximately 20–25%).