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  • Manager, Trial Delivery Management Raritan
  • Johnson & Johnson in Raritan, NJ, Switzerland
  • jobs
  • 6 days ago

jobs description

The Manager, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews... and local challenges that could impact overall study delivery.

Principal Responsibilities:

Create and update critical trial-specific documents (e.g. Monitoring Guidelines, Informed Consent Form, Investigational Medical 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, be 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.

Additional Responsibilities may Include:

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.

Foster employee engagement, inclusion, and Credo Behaviors
Raritan NJ United States (+11 others)

salary-criteria

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