Clinical Trial Manager

2 weeks ago

Raleigh, United States Advanced Recruiting Partners Full time

Job Description:

We are seeking an experienced and highly motivated Clinical Trial Manager (CTM) with a strong background in respiratory clinical trials to join our growing clinical operations team. As a Clinical Trial Manager, you will play a key role in managing and overseeing the execution of clinical trials for respiratory therapies, ensuring that trials are conducted according to regulatory requirements, on time, and within budget. The ideal candidate will have hands-on experience in managing end-to-end clinical trial activities, with a strong understanding of the complexities and nuances of respiratory-focused studies.

This is a great opportunity for a dedicated clinical professional to work in a dynamic biotech environment, driving innovative treatments in respiratory diseases and contributing to the future of healthcare.


Key Responsibilities:

  • Clinical Trial Management: Lead the planning, execution, and close-out of respiratory clinical trials, ensuring all milestones are achieved in a timely manner, while maintaining high quality and regulatory compliance.
  • Study Design & Protocol Development: Contribute to the design and development of clinical trial protocols, informed consent forms, case report forms (CRFs), and other essential study documents. Ensure alignment with regulatory requirements and therapeutic goals.
  • Site Management & Monitoring: Manage site selection, initiation, and training. Oversee the activities of clinical sites, ensuring adherence to study protocols, compliance with Good Clinical Practices (GCP), and consistent progress toward patient recruitment, enrollment, and retention goals.
  • Budget & Timeline Management: Develop and manage trial budgets and timelines. Track progress against key deliverables, making adjustments as needed to stay on track with study goals and timelines.
  • Team Leadership: Work closely with cross-functional teams (including Clinical Research Associates, Data Management, Regulatory, and Medical Affairs) to ensure seamless collaboration and smooth trial execution. Provide leadership and guidance to site coordinators and other team members.
  • Regulatory Compliance & Quality Control: Ensure that all clinical trial activities comply with local, national, and international regulatory requirements, including ICH-GCP, FDA, EMA, and other relevant health authorities. Maintain thorough documentation of study activities, adverse events, and study progress.
  • Risk Management & Problem Solving: Identify and manage risks proactively, troubleshooting operational issues and resolving challenges related to patient recruitment, data integrity, and site performance. Escalate issues as necessary to senior management.
  • Patient Safety & Data Integrity: Ensure that patient safety is prioritized throughout the trial, and that clinical data is accurate, consistent, and in compliance with regulatory requirements.
  • Vendor & CRO Management: Manage relationships with external partners, including Contract Research Organizations (CROs), vendors, and clinical sites. Oversee the performance of these third-party vendors to ensure that deliverables are met and quality standards are maintained.
  • Communication & Reporting: Provide regular updates and reports to senior management on study progress, including enrollment, timelines, budget, and any issues or challenges encountered. Act as the main point of contact for internal and external stakeholders on study-related matters.

Required Qualifications:

  • Experience: 5+ years of clinical trial management experience, with a focus on respiratory clinical trials (e.g., asthma, COPD, pulmonary diseases, etc.). Experience managing Phase I through Phase III trials is preferred.
  • Therapeutic Expertise: Solid understanding of respiratory disease areas, treatment paradigms, and clinical development strategies for respiratory therapies.
  • Regulatory Knowledge: Thorough knowledge of regulatory requirements and guidelines (e.g., ICH-GCP, FDA, EMA) relevant to the conduct of clinical trials in the respiratory space.
  • Project Management Skills: Proven ability to manage multiple projects simultaneously, balancing priorities, resources, timelines, and budgets. Ability to anticipate risks and implement mitigation strategies.
  • Communication Skills: Excellent communication, presentation, and interpersonal skills. Ability to work effectively with internal teams, external partners, and clinical sites.
  • Leadership Ability: Experience leading cross-functional teams, managing clinical research associates, and ensuring the success of trial execution.
  • Problem-Solving Skills: Strong analytical and problem-solving skills with the ability to think critically, troubleshoot, and resolve issues that arise during the course of a trial.
  • Education: Bachelor’s degree in Life Sciences, Nursing, or a related field. Advanced degree (e.g., MSc, PhD, or equivalent) is a plus.

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