Clinical Trial Manager

Immatics N.V-posted 3 months ago

Full-time • Mid Level

Houston, TX

501-1,000 employees

Professional, Scientific, and Technical Services

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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. 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.

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)
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

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
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

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

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
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

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