About the role

Lead, Trial Delivery Manager overseeing oncology clinical trials for innovative medicine at Johnson & Johnson. Manage vendor relations, trial documents, and operational strategies for effective study delivery.

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, including set-up, SOW creation and budget oversight
Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews)
Support development of program-level compound training, collaborating with Clinical / CTL&T / Medical writing
Provide input into trial level operational strategies
Resolve trial-related issues and mitigate trial-related risks
Participate in process improvement activities at a trial, compound & cross-DU level
Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues
Mentor & support onboarding of new team members, particularly those in Trial Management

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)
Must have the ability to manage multiple aspects of execution of a clinical trial
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
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
Experience leading without authority in multi-functional matrixed and global environments
Excellent decision-making, analytical and strong financial management skills
Experience mentoring/coaching others
Strong project planning/management (e.g., organization, problem-solving, adaptability) communication skills
Ability to think strategically and work through ambiguous situations
Ability and experience to lead the Study Management Meetings
Experience and skills utilizing technology (e.g., tools, systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight
Travel up to 15-20% of the time, defined by business needs

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for Washington residents - 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