Immatics Us - Houston, TX

posted 2 months ago

Full-time - Mid Level
Remote - Houston, TX
Chemical Manufacturing

About the position

The Clinical Trial Manager (CTM) at Immatics US is a pivotal role within the Clinical Operations department, primarily responsible for ensuring that clinical trial site management and monitoring activities are conducted in compliance with Good Clinical Practice (GCP) guidelines, as well as national and local regulations. This position is fully remote, allowing for flexibility while maintaining a structured work environment that simulates an office setting. The CTM will collaborate closely with the Clinical Operations Lead (COL) to set targets for clinical monitoring activities, ensuring that all trial records are maintained in accordance with project goals. In this role, the CTM will oversee the clinical trial site feasibility and selection process, create and implement trial-specific plans and documents, and ensure timely regulatory submissions. The CTM will also drive the clinical site initiation process, actively contribute to site management, and maintain strong relationships with clinical trial sites. This includes organizing project-specific training for Clinical Research Associates (CRAs) and reviewing trip reports to provide expert advice. The CTM will monitor the progress of clinical trials, particularly focusing on patient recruitment and data capture, and will conduct Monitoring Oversight Visits to ensure compliance with protocols and GCP standards. Additionally, the CTM will manage protocol deviations and contribute to the continuous improvement of clinical operations processes. The ideal candidate will possess advanced project management skills, a proactive attitude, and the ability to analyze and communicate complex problems effectively. This position requires a strong commitment to quality and efficiency, with the ability to meet timelines and milestones within the scope of the role.

Responsibilities

  • Collaborate with COL to set targets for clinical monitoring activities and ensure compliance with project goals.
  • Conduct and oversee the clinical trial site feasibility and site selection process.
  • Create, maintain, and implement trial-specific plans, tools, and documents required per SOP.
  • Oversee or perform collection of clinical trial site-specific documents ensuring on-time regulatory submissions according to local requirements.
  • Drive the clinical site initiation and greenlight process according to project goals.
  • Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships.
  • Organize and oversee project-specific training for CRAs and clinical trial sites.
  • Review trip reports and provide day-to-day expert advice to CRAs.
  • Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives.
  • Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA performance.
  • Manage protocol and GCP deviations as Deviation Manager according to SOP.

Requirements

  • Bachelor's degree, preferably in life science, nursing, or equivalent.
  • At least 2 years of on-site monitoring experience and 2 years of Clinical Trial Manager experience in the pharmaceutical or biotechnology industry.
  • Comprehensive knowledge of ICH-GCP, FDA, EMA, and applicable local regulations and laws.
  • Understanding of basic medical oncology terminology and science preferable.
  • Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS).
  • Advanced understanding of priorities within own scope with limited interaction with the supervisor.
  • Proactively driving quality and efficiency to meet timelines and milestones in own scope.
  • Advanced presentation and organizational skills.

Nice-to-haves

  • Proactively driving company standards, global harmonization, and innovation in own scope.
  • Advanced reflection on complex process structures and connections fostering innovation and development in own area of expertise.
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