Clinical Trial Manager

4 weeks ago

Houston, Texas, United States Immatics NV Full time
Clinical Trial Manager Job Summary

This is a remote position that requires a Clinical Trial Manager to oversee clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs. The ideal candidate will have at least 2 years of on-site monitoring and 2 years of CTM experience in the pharmaceutical or biotechnology industry.

Key Responsibilities:
  • Collaborate with COL to set targets for clinical monitoring activities and ensure recording of the trial in 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 and 2 years of CTM experience in the pharmaceutical or biotechnology industry.
  • Comprehensive knowledge of ICH-GCP, FDA, and 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.
Work Environment:

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment, and supplies on a regular basis. Noise levels should be at a level that allows for proper communication with other members virtually.

Physical Demands:
  • Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly, or quickly.
  • Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group, or conference, telephone, and other sounds.
  • Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10-key pad, touch screens, and others.
  • Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
  • Sitting - remaining in a sitting position for at least 50% of the time.
Travel Required: 50%-70%

Required Education and Experience:
  • Bachelor's degree, preferably in life science, nursing, or equivalent.
  • At least 2 years of on-site monitoring and 2 years of CTM experience in the pharmaceutical or biotechnology industry.
  • Comprehensive knowledge of ICH-GCP, FDA, and 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.
Preferred Education and Experience:
  • 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.
Work Authorization/Security Clearance Requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action/EEO Statement:

Immatics is an equal opportunity employer. All employment decisions, including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.

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