Lead, Trial Delivery Management

Job Function

R&D Operations

Clinical Trial Project Management

Professional

Spring House, Pennsylvania, United States of America

• 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 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., align feasibility strategy with local teams, perform country‑level risk reviews).
• 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.

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.
• Must 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.

Travel up to 15‑20% of the time, defined by business needs.

Pharmaceutical, Biopharmaceutical, Biotechnology

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).