Clinical and Operation Manager

Overview

Job Title: Clinical and Operation Manager

Job Number: 115108

Location: Rockville,US

• Lead end-to-end management of clinical trials, including study planning, timeline and budget management, CRO and vendor oversight, site start-up, enrollment tracking, monitoring oversight, and study close-out.
• Ensure compliance with FDA regulations, ICH-GCP, and internal SOPs, and support regulatory activities including IND amendments, safety reporting, and regulatory interactions.
• Coordinate cross-functional teams including regulatory, medical, data management, pharmacovigilance, manufacturing, and finance to ensure aligned execution and high-quality trial delivery.
• Oversee trial deliverables including protocol execution, data quality oversight, query resolution, database lock support, clinical study report (CSR) preparation, and regulatory documentation.
• Identify and proactively mitigate operational risks, timeline delays, and budget overruns; maintain accurate trial documentation, dashboards, and executive reporting.
• Lead investigational product (IP) logistics and international shipment coordination for clinical trials, including coordination with China-based manufacturing or supply partners, importation from China to the U.S., customs clearance support, temperature control compliance, documentation readiness, and delivery to clinical sites or depots.

• Lead the continued execution and completion of the pharmaceutical wholesale distribution licensing process, including responding to regulatory inquiries, providing supplemental documentation, inspection preparation, and final approval readiness. Maintain ongoing license compliance post-approval, including renewals, audits, SOP updates, and regulatory reporting, ensuring operational readiness aligned with state Board of Pharmacy, FDA, DSCSA, and GDP requirements.
• Act as the primary operational lead interfacing with China-based manufacturers and partners to execute product onboarding, documentation readiness, and shipment preparation. Translate commercial objectives into executable operational plans, ensuring timely delivery of compliant materials and documentation.
• Lead end-to-end execution of manufacturing readiness, international logistics, export and import documentation, customs clearance, and U.S. import compliance.
• Ensure full traceability, temperature control, chain-of-custody integrity, and regulatory compliance across cross-border and domestic distribution.
• Drive issue resolution and continuous improvement across timelines, quality, documentation, and logistics execution.

• Master’s degree or above in Life Sciences, Medicine, Pharmacy, or a related field
• Minimum of 3 years of experience in clinical operations or clinical project management within biotech, pharma, or a CRO environment
• Hands-on experience supporting clinical trial start-up
• Working knowledge of FDA regulations and ICH-GCP requirements
• Experience supporting regulatory or compliance-related activities, including documentation preparation and coordination
• Must be legally authorized to work in the United States
• Bilingual in English and Mandarin, with the ability to work professionally in both languages

Final date to receive applications: