Clinical Project Manager

Job not on LinkedIn

October 30

🤠 Texas – Remote

Although this job is listed in Texas, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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INSIGHTEC

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Healthcare • Pharmaceuticals • Science

INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.

201 - 500 employees

💊 Pharmaceuticals

🔬 Science

💰 $100M Debt Financing on 2022-08

📋 Description

• 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.

🎯 Requirements

• Bachelor's or Master's degree in life sciences or a related field • 7+ years of experience as a Clinical Project Manager for Class II/III device studies • 3+ years of regulatory/clinical trial experience in the medical device industry • Demonstrates working knowledge of clinical trial design • Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents • Knowledge of financial principles in budgeting, budget negotiation, & contracts management • Demonstrates data management skills, tracking study metrics, and adherence to study protocol • Fluent in English with oral presentation and training capabilities • Able and willing to travel as needed, up to 30% • Expertise in GCP and regulatory requirements. • Strong leadership and team management skills.

🏖️ Benefits

• Competitive perks and benefits in each region • Flexible work environment • Professional development opportunities