Clinical Trial Manager

2 weeks ago

Raleigh, North Carolina, United States WilsonHCG Full time

Our client is a leading biotechnology company specializing in the development of innovative CAR-T, cell, and gene therapies. Our mission is to transform the lives of patients by advancing breakthrough treatments. We are dedicated to fostering a collaborative and dynamic environment where scientific innovation thrives.

Job Summary: We are seeking a highly skilled and experienced Clinical Trial Manager to oversee and manage clinical trials in the CAR-T, cell, and gene therapy space. The successful candidate will be responsible for planning, executing, and monitoring clinical trials, ensuring compliance with regulatory requirements, and delivering high-quality data to support our product development goals.

Key Responsibilities:

Clinical Trial Management: Oversee the planning, implementation, and management of clinical trials from start-up through close-out phases.Protocol Development: Collaborate with cross-functional teams to develop and finalize clinical trial protocols, informed consent documents, and other essential study documents.Regulatory Compliance: Ensure all clinical trials are conducted in compliance with FDA, EMA, and ICH guidelines as well as local regulatory requirements.Vendor Management: Select, manage, and oversee Contract Research Organizations (CROs) and other external vendors to ensure timely and high-quality deliverables.Budget Management: Develop and manage trial budgets, ensuring efficient use of resources and adherence to financial plans.Site Management: Oversee site selection, initiation, monitoring, and close-out activities to ensure trial sites comply with study protocols and regulatory requirements.Data Management: Ensure accurate, timely, and complete data collection, monitoring data quality, and collaborating with data management teams to address data queries.Team Leadership: Lead and mentor clinical trial associates and other team members, fostering a collaborative and productive work environment.Risk Management: Identify potential risks and develop mitigation strategies to ensure the successful execution of clinical trials.Reporting: Prepare and present regular updates and reports to senior management, project teams, and other stakeholders.

Qualifications:

Education: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree (Master's or PhD) preferred.Experience: Minimum of 5-7 years of experience in clinical trial management, with a focus on CAR-T, cell, or gene therapy trials.Regulatory Knowledge: In-depth understanding of FDA, EMA, and ICH guidelines as well as local regulatory requirements.Technical Skills: Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.Leadership Skills: Proven ability to lead and manage cross-functional teams and external vendors.Communication: Excellent written and verbal communication skills, with the ability to effectively present information to diverse audiences.Problem-Solving: Strong analytical and problem-solving skills, with the ability to anticipate and address issues proactively.Attention to Detail: High level of attention to detail and accuracy in all aspects of clinical trial management.

Benefits:

Competitive salary and bonus structureComprehensive health, dental, and vision insurance401(k) with company matchPaid time off and holidaysProfessional development opportunitiesCollaborative and innovative work environment

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