Clinical Trial Manager

Immatics•Houston, TX

2d•Remote

About The Position

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! 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 cells 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

Requirements

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) (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
Legal eligibility to work in the United States is required.

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

Responsibilities

Collaborate 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

Benefits

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 at 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.