Senior Clinical Trial Manager

Parexel is seeking a Senior Clinical Trial Manager (Sr. CTM) to oversee clinical trial operations from start-up to database lock, ensuring compliance with GCP and SOPs. The role involves managing study activities, vendor relationships, and ensuring trial milestones are met, contributing to the development of therapies that benefit patients.

Location: United States

Responsibilities

• Manages all operational aspects for implementation of clinical trials from start-up through database lock.
• Manages study-related service providers and serves as primary contact for CROs, study staff, and labs.
• Participates in CRO selection, validates scope of work, supports outsourcing, reviews quality metrics, and shares lessons learned.
• Manages vendor meetings, site investigator grants, and study protocol review.
• Coordinates and manages investigator meetings, site selection, IRB submissions, and trial planning.
• Leads or supports clinical operational team meetings, reviews key documents, oversees UAT for trial systems.
• Provides content for study systems, approves invoices, tracks vendor change orders.
• Develops study materials like monitoring plans, data management plans, and patient instructions.
• Coordinates site monitoring, maintains trial master files, supports safety monitoring, and manages audit responses.
• Assesses patient recruitment and trial progress, supports safety reporting, and maintains performance metrics.

Requirements

• Minimum of 5 years of experience in clinical study leadership in the biopharmaceutical industry.
• Global clinical trial experience preferred.
• Ability to independently lead a clinical study from startup to database lock and regulatory submission.
• Strong management skills of CROs, site monitoring, and clinical quality compliance.
• Knowledge of GCP, FDA regulations, and data safety monitoring activities.
• Bachelor’s degree in health or biological sciences; master's degree a plus.