Clinical Trials Manager (CTM)

Photocure

20h•Remote

About The Position

An experienced clinical operations professional who manages biomarker clinical trials and in vitro diagnostic (IVD) kit studies from start-up through close-out. The role ensures studies are delivered on time, within budget, and in compliance with ICH-GCP and FDA requirements, generating high-quality clinical evidence to support regulatory submissions and market access. This is a US-based remote position, with travel to clinical sites and meetings as needed (approximately 20–25%).

Requirements

Bachelor’s degree in life sciences, nursing, or a related field.
At least 6 years of clinical research experience in the diagnostics, medical device, biotech, or pharmaceutical industry, including independent management of multi-site clinical studies.
Strong working knowledge of ICH-GCP and FDA regulations for IVD and medical device clinical studies, including 21 CFR Parts 50, 56, 809, and 812, and ISO 20916.
Working knowledge and competencies in ISO 14155.
Familiarity with HIPAA.
Proven clinical project management skills, including planning, budgeting, risk management, and delivery of multi-site studies.
Experience managing CROs and vendors, including contract and budget negotiation.
Demonstrated experience managing CROs and clinical sites.
Proficiency with CTMS, EDC, eTMF systems, and MS Office.
Highly organized and detail-oriented.
Excellent written and verbal communication skills and the ability to work independently and collaborate effectively in a remote, international team.
Willingness to travel to clinical sites and meetings as needed, approximately 20–25%.
Based in the United States.

Nice To Haves

Advanced degree.
Experience with biomarker studies.
Oncology or urology experience.
Experience with IVD kit clinical performance studies supporting FDA submissions, such as 510(k), De Novo, or PMA.
Clinical research certification, such as ACRP CCRA/CCRC or SOCRA CCRP.

Responsibilities

Plan and lead operational execution of biomarker clinical trials and IVD kit clinical performance studies, from protocol development through database lock and clinical study report.
Provide operational input on protocol design, sample-handling workflows, and statistical planning to ensure feasibility and regulatory alignment.
Contribute to and review study documents, including protocols, informed consent forms, CRFs/eCRFs, monitoring plans, budgets, and timelines.
Lead site feasibility, selection, and qualification; manage clinical trial agreements, site budgets, and IRB/ethics submissions.
Plan and oversee studies from a GCP perspective, including clinical trial management, risk-responsive project management, site management plans, and related documentation.
Manage CROs and other vendors, overseeing scope, deliverables, performance, and invoices.
Oversee site monitoring activities and review monitoring reports; drive timely resolution of issues and protocol deviations.
Track enrollment, milestones, budgets, and risks, and implement mitigation plans to keep studies on schedule.
Own study budgets, including forecasting, internal accrual tracking, and change-order management.
Lead financial oversight of CRO and vendor contracts, including negotiation of amendments.
Ensure data quality through data review, query resolution, and database lock in partnership with data management and biostatistics.
Maintain a complete, audit-ready Trial Master File (TMF) and manage deviations and CAPAs.
Establish and lead CRO governance meetings, including operational reviews, KPI reviews, and quality reviews.
Ensure CRO adherence to KPIs, quality metrics, and contractual obligations; drive escalation pathways and corrective actions when performance deviates.
Ensure studies comply with ICH-GCP E6, applicable FDA regulations (21 CFR Parts 50, 56, 809, and 812), ISO 20916, and company SOPs.
Support FDA interactions and submissions, such as Pre-Submissions/Q-Subs, IDE, 510(k), De Novo, and PMA, by providing clinical study documentation and responses to questions.
Contribute to development and continuous improvement of clinical operations SOPs and processes.
Implement and maintain risk-based monitoring strategies and quality oversight plans.
Lead risk assessments and ensure mitigation plans are documented and executed.
Partner with QA to prepare for audits and inspections and lead operational readiness activities.
Serve as the primary operational contact for investigators, site staff, CROs, and vendors.
Partner with medical affairs, regulatory affairs, and quality teams to align study execution with company objectives.
Provide management with regular study status updates, metrics, and risk assessments.