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Johnson & Johnson Innovative Medicine · 11 hours ago

Manager, Trial Delivery Manager

Spring House, PA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases. The Manager, Trial Delivery Management is responsible for executing study-level activities, managing vendor relationships, and overseeing local operational delivery to ensure successful clinical trial execution.

Pharmaceuticals

Responsibilities

Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation)

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, aware of all projects conducted across countries)

Support development of program-level compound training, collaborating with Clinical / CTL&D 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, as needed

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

Foster employee engagement, inclusion, and Credo Behaviors

Qualification

Clinical Trial ManagementPharmaceutical DevelopmentProject ManagementBudgetingAnalytical ReasoningLeadership SkillsMentorshipCommunication SkillsPresentation Skills

Required

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Minimum of 8 years in Pharmaceutical, Healthcare or related industries

Experience in and knowledge of the pharmaceutical development process

Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial

2-3 years' experience leading multiple aspects of a global clinical trial

Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness

Experience of leading without authority and in multi-functional matrixed and global environments

Excellent decision-making, analytical and strong financial management skills are essential to this position

Operate and execute with limited supervision

Experience mentoring/coaching others

Strong project planning/management, communication and presentation skills are required