Clinical Trial Manager
Immatics
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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
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) 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.
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.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementclinical monitoringsite feasibilityregulatory submissionsGCP deviationsclinical trial data capturepatient recruitmentclinical operationsSOP compliancemedical oncology terminology
Soft Skills
organizational skillspresentation skillscollaborationproactive problem-solvingrelationship managementcontinuous improvementexpert advicedriving qualityefficiencytime management
Certifications
bachelor's degreelife science degreenursing degreeClinical Trial Manager experienceICH-GCP knowledgeFDA regulations knowledgeEMA regulations knowledge