Clinical Trials Manager

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Photocure

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

Photocure is a specialty biopharmaceutical company focused on improving the detection and management of bladder cancer. The company develops and commercializes precision diagnostic and therapeutic solutions, partners with healthcare and research organizations, and supports real-world evidence, patient registries, and health-economic analyses to advance urologic oncology care globally.

📋 Description

• 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 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 site feasibility, selection and qualification • Manage clinical trial agreements, site budgets and IRB/ethics submissions • Plan and oversee studies from a GCP perspective, including project management, risk response and site management plans • Manage CROs and vendors, overseeing scope, deliverables, performance and invoices • Oversee site monitoring and resolve issues and protocol deviations • Track enrollment, milestones, budgets and risks; implement mitigation plans • Own study budgets, forecasting, accrual tracking and change-order management • Lead financial oversight and negotiation of CRO and vendor contracts • Ensure data quality through data review, query resolution and database lock • Maintain an audit-ready Trial Master File and manage deviations and CAPAs • Establish and lead CRO governance meetings and monitor KPIs, quality metrics and contractual obligations • Drive escalation pathways and corrective actions for CRO performance issues • 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 • Improve clinical operations SOPs and processes • Implement risk-based monitoring strategies and quality oversight plans • Lead risk assessments and document and execute mitigation plans • Partner with QA on audits and inspections and lead operational readiness activities • Serve as primary operational contact for investigators, site staff, CROs and vendors • Partner with medical affairs, regulatory affairs and quality teams • Provide study status updates, metrics and risk assessments to management

🎯 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 industry • 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 • ISO 20916 working knowledge and competencies • ISO 14155 working knowledge and competencies • 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 • Proficiency with CTMS, EDC, eTMF systems and MS Office • Excellent written and verbal communication skills • Ability to work independently and collaborate effectively in a remote, international team • Based in the United States • Biomarker study experience preferred • Oncology or urology experience is an advantage • Experience with IVD kit clinical performance studies supporting FDA submissions preferred • Clinical research certification such as ACRP CCRA/CCRC or SOCRA CCRP is a plus

🏖️ Benefits

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