Lead, Trial Delivery Management

About the role

The Lead, 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.

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, 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.

Requirements

• BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
• 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.
• Possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience 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.