Lead, Trial Delivery Management

We are searching for the best talent for Lead, Trial Delivery Management.

The Lead, Trial Delivery Manager (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 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.

Required Minimum Education: Bachelor’s degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

Required Knowledge and Experience:

• 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.

• Minimum of 2 years’ experience supporting multiple aspects of a global clinical trial.

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

• Experience leading without authority and in muti-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.

• Immunology clinical trial experience is preferred.

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

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