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Clinical Trial Manager
ImmaticsIndianapolis, IN, US7 days ago
Job type
- Full-time
Job descriptionCollaborate with COL (Clinical Operations Lead) 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 (Standard Operating Procedure) (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 (Clinical Research Associate) 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 (Clinical Research Associate) performance Manage protocol and GCP deviations as Deviation Manager according to SOP Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates Min. bachelor's degree, preferably in life science or nursing, or equivalent At least 2 years of on-site monitoring and 2 years of CTM (Clinical Trial Manager) experience in the pharmaceutical or biotechnology industry (including all clinical monitoring visit types) Comprehensive knowledge of ICH-GCP, FDA (Food and Drug Administration) and EMA (European Medicines Agency) 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 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 Proficient verbal and written communication skills in English with high degree of tact and diplomacy 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. Lifting raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing Exerting force upon an object so that the object moves away from the object. Pulling Exerting force upon an object so that the object moves toward the force. Sitting remaining in a sitting position for at least 50% of the time. Standing / Walking remain on one's feet in an upright position at a workstation. Stooping occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time Off, granted up front each year and prorated for first and last year of employment Sick Time Off 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities. Fast paced, high demand collaborative and dynamic environment.
Join Immatics and Shape the Future of Cancer Immunotherapy
Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.
Why Join Us?
- Innovative Environment : Help to pioneer advancements in cancer immunotherapy.
- Collaborative Culture : Be part of a diverse team dedicated to your professional growth.
- Global Impact : Contribute to therapies that make a lasting impact on patients globally.
We are seeking a Clinical Trial Manager to support our U.S. Clinical Operations team. The CTM will oversee site management and monitoring activities in compliance with GCP, applicable regulations, and SOPs.
FLSA Classification : Salary, Exempt Schedule : 8 : 00 AM 5 : 00 PM; Monday to Friday Reports to : Associate Director, Team Lead Site Operations Location : Fully Remote
What You'll Do :
Secondary Functions :
Required Experience and Education :
Competencies :
Work Environment :
This is a sedentary position (at least 50% of the time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs. is expected. Willingness to travel up to 50% required.
Physical Demands :
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.
What Do We Offer?
At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics :
Comprehensive Benefits :
Professional Growth :
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Clinical Trial Manager • Indianapolis, IN, US
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