[Hiring] Clinical Trials Manager @Photocure

Role Description

Experienced clinical operations professional responsible for managing biomarker clinical trials and in vitro diagnostic (IVD) kit studies from study start-up through close-out. 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. US-based, remote position.

Responsibilities and Activities

• Study Planning and Start-up:
  • Plan and lead the 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 to ensure feasibility and regulatory alignment.
  • Contribute to and review study documents, including protocols, informed consent forms, CRFs/eCRFs, monitoring plans and study budgets and timelines.
  • Lead site feasibility, selection and qualification; manage clinical trial agreements, site budgets and IRB/ethics submissions.
  • Planning and oversight of the study from GCP point of view (e.g. clinical trial management, establishing project management in response to study risk, site management plans and associated documentation).
• Study Execution and Oversight:
  • Manage CROs and other vendors; oversee scope, deliverables, performance and invoices.
  • Oversee site monitoring activities and review monitoring reports; drive timely resolution of issues and protocol deviations.
  • Track enrollment, milestones, budget and risks; 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 (e.g., operational reviews, KPIs, quality reviews).
  • Ensure CRO adherence to KPIs, quality metrics, and contractual obligations.
  • Drive escalation pathways and corrective actions when CRO performance deviates.
• Regulatory and Quality:
  • 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 (e.g., Pre-Submissions/Q-Subs, IDE, 510(k), De Novo, PMA) by providing clinical study documentation and responses to questions.
  • Contribute to the 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; lead operational readiness activities.
• Cross-functional Collaboration:
  • 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 regular study status updates, metrics and risk assessments to management.

Qualifications

• Strong working knowledge of ICH-GCP and FDA regulations for IVD and medical device clinical studies (21 CFR Parts 50, 56, 809, 812) and ISO 20916; familiarity with HIPAA.
• Proven clinical project management skills: planning, budgeting, risk management and delivery of multi-site studies.
• ISO 14155 working knowledge and competencies.
• Experience managing CROs and vendors, including contract and budget negotiation.
• Proficiency with CTMS, EDC, eTMF systems and MS Office.
• Highly organized and detail-oriented.
• Excellent written and verbal communication skills; able to work independently and collaborate effectively in a remote, international team.
• Willingness to travel to clinical sites and meetings as needed (approximately 20–25%).

Requirements

• Bachelor’s degree in life sciences, nursing or a related field; advanced degree is a plus.
• 6+ years of clinical research experience in the diagnostics, medical device, biotech or pharmaceutical industry, including independent management of multi-site clinical studies.
• Experience with biomarker studies preferred; oncology or urology experience is an advantage.
• Experience with IVD kit clinical performance studies supporting FDA submissions (e.g., 510(k), De Novo, PMA) preferred.
• Demonstrated experience managing CROs and clinical sites.
• Clinical research certification (e.g., ACRP CCRA/CCRC or SOCRA CCRP) is a plus.
• Based in the United States; remote position.