Essential functions:
- Support clinical trial site feasibility
- Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring and close-out.
- Support the maintenance of the Investigator Site Files and Trial Master Files
- Conduct all aspects of site management as prescribed in the clinical trial specific functional plans.
- Prepare accurate and timely monitoring visit reports
- Review progress of clinical trials, especially patient recruitment and clinical trial data capture and initiate appropriate actions to achieve objectives
Secondary functions:
- Maintain clinical trial tracker
- Organize and present clinical trial content at Investigator Meetings
- Act as a primary contact for clinical trial supplies and other suppliers (vendors)
- Participate in the development of Case Report Forms and clinical trial documents
- Prepare and review Standard Operations Procedures and Working Instructions as well as template documents
Competencies
- Very good communication skills
- Positive attitude and willingness to learn and contribute in a team
- Very good organizational skills to work efficiently, good time management
- Exceptional attention to detail
- Good team player with excellent negotiation and conflict resolution skills
- Demonstrates ability to take initiative and work independently
- Ability to prioritize and adapt quickly in a fast-paced and changing industry
- Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence
Work environment:
This position works remotely or in the office in a typical office environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Travel is an essential function of the job. Most travel is arranged by flight or train. During the travel time, clinical monitoring activities, especially preparation and documentations, should be completed as much as possible.
Physical demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hear, use hands to finger, grasp, handle, feel or operate objects, tools or controls. The employee is occasionally required to climb, balance, stoop, kneel, crouch, reach with hands and arms, walk; lift push or pull objects up to 20 pounds. Hand-eye coordination necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Travel required:
Travel is an essential function of the job (>75%)
Required education and experience
- Bachelor’s degree preferably in life science or nursing, or you have a comparable education.
- 4-6 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry.
- Understanding of medical oncology terminology and science.
- In-depth knowledge of ICH-GCP, FDA, EMA and applicable local regulations and laws.
- Valid Driver’s license
- Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)
Preferred education and experience
- Excellent English knowledge (written and spoken)
Additional eligibility requirements: none
Work authorization/security clearance requirements
Must be eligible to work in the US legally at any time during 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.
