Teams at Parexel

Perform clinical data management for Phase I-IV studies: design and test eCRFs/EDC, develop edit checks and DMPs, manage queries, reconcile external data and SAEs, support database lock, and collaborate with cross-functional teams and vendors.

The role involves managing clinical trial budgets and contracts, negotiating with stakeholders, and ensuring compliance with regulations. Responsibilities include budget development, contract negotiations, and cross-functional collaboration to optimize clinical research support.

Lead global regulatory strategy and project execution across product development, registration, and post-marketing activities. Partner with Global Regulatory Leads, coordinate cross-functional teams, manage milestones, risks, timelines, and submission readiness, and facilitate regulatory subteam meetings. Prepare dashboards and scenario plans for senior stakeholders while supporting U.S., EU, and global regulatory programs, including IND, BLA, and MAA submissions for vaccines and other therapies.