Clinical Trial Manager (1029)

at  Immatics US

FLSA Classification: Exempt/Salary
Schedule: Monday – Friday; 8:00 am – 5:00 pm; Evening and weekend work as necessary
Department: Clinical Operations
Reports to: Associate Director Clinical Operations
Supervisory responsibilities: No
Location: Fully Remote
Position Summary/objective:
The primary responsibility of this position is to ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs, including but not limited to: (See Essential Functions and Secondary Functions)

Essential functions:

• Collaborate with COL to set targets for clinical monitoring activities, and ensuring the 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 (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan)
• Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements
• Driving 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 initiates 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

  Secondary functions:
  Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates.

  Competencies:

• Advanced team leader skills and strong team player

• Proactive attitude with strong sense of responsibility within own scope
• Positive attitude and willingness to learn and contribute to a team
• Proficient time management to work efficiently and economically
• Analytical reasoning and advanced project management skills
• Strong ability to identify, deeply analyze and communicate problems

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 which would allow 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% Travel is required

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 (including all clinical monitoring visit types)
• 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, medicalconditions, 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

• Collaborate with COL to set targets for clinical monitoring activities, and ensuring the 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 (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan)
• Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements
• Driving 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 initiates 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 SO