INSIGHTEC

Clinical Operations

• Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
• Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design.
• Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports.
• Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable.
• In partnership with R&D Program Management, develop and drive cross functional study timelines related to trial setup and execution.
• Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
• Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines.
• Foster a collaborative team environment focused on operational efficiency and continuous improvement.
• Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable.
• Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately.
• Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs.
• Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
• Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
• Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
• Negotiate contracts and budgets with clinical vendors and investigators.
• Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
• Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
• Perform risk assessment and management, addressing issues proactively to mitigate operational issues.

Clinical Project Manager

Director

• Provide strategic leadership and oversight of global clinical development programs across multiple therapy platforms and geographies.
• Serve as the clinical research authority within cross-functional and global teams, driving the successful execution of clinical strategies that support regulatory approvals, commercialization, and long-term growth.
• Build and scale organizational capabilities to conduct clinical programs under responsibility.
• Mentor high-performing teams and shape the company’s global clinical affairs vision.
• Ensure excellence in design, execution, data integrity, and compliance across global clinical programs.

Clinical Project Manager

Director, Clinical Affairs