Teams at Parexel

Manages global clinical trial operations from protocol design through study closeout, including CRO and vendor oversight, regulatory tracking, recruitment, budgets, timelines, risk mitigation, trial documentation, training, and stakeholder coordination. Supports inspection readiness, process improvement, team onboarding, and operational strategy across Phase I-IV studies.

Provides CMC regulatory strategy and post-approval support for biologics and plasma products. Develops submission plans, assesses manufacturing and quality changes, reviews technical documentation, coordinates global regulatory submissions, manages regulatory information systems, and mitigates compliance risks. Requires pharmaceutical regulatory affairs experience, biologics CMC expertise, and knowledge of global post-approval requirements.

Provides operational and administrative support for clinical trials from study start-up through closeout. Responsibilities include maintaining tracking systems and study files, coordinating training and meetings, managing sample and supply tracking, supporting vendors and study teams, performing document quality checks, archiving in the TMF, and assisting with budget tracking. Requires knowledge of clinical operations, ICH-GCP, eTMF systems, and essential trial documents.