Lead, Trial Delivery Manager managing oncology clinical trials at Johnson & Johnson. Oversee clinical research activities and ensure operational excellence across multiple locations in the U.S.
Responsibilities
Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation)
Manage vendor set up and management of day-to-day study vendor activities
Responsible for country / regional coordination of trial management activities and oversight
Support development of program-level compound training
Provide input into trial level operational strategies
Resolve trial-related issues and mitigate trial-related risks
Participate in process improvement activities
Provide support during Health Authority inspections and on the identification of risks and mitigation plans
Mentor & support onboarding of new team members
Requirements
BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries
Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV)
2-3 years’ experience supporting multiple aspects of a global clinical trial
Minimum of 2 years of oncology clinical trial experience
CAR-T experience would be a plus
Excellent decision-making, analytical and strong financial management skills are essential to this position
Strong project planning/management, communication and presentation skills are required
Ability to think strategically and work through ambiguous situations
Experience utilizing technology to obtain reports for efficient metric oversight
Benefits
medical, dental, vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
vacation - up to 120 hours per calendar year
sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
holiday pay, including floating holidays - up to 13 days per calendar year
work, personal and family time - up to 40 hours per calendar year
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