Project Manager, Clinical Operations

Overview

• Lead clinical trial management for multi-country studies, ensuring compliance with protocols and regulations.
• Collaborate with vendors, CROs, and investigative sites to optimize trial execution.
• Develop and review clinical SOPs, study plans, and associated documents.
• Coordinate site feasibility, qualification, and selection processes effectively.
• Oversee study trackers, timelines, and budgets to ensure progress alignment.
• Prepare and present trial updates to executive management and cross-functional teams.
• Ensure proper management of study-related supplies and documentation.
• Facilitate communication within clinical and executive teams for project success.

Key Responsibilities & Duties

• Manage clinical trial processes from start-up through closeout, adhering to GCP and corporate standards.
• Lead evaluation and selection of CROs and investigational sites.
• Develop study-specific tools and collaborate with vendors to create study plans.
• Coordinate site contracts, budgets, and review clinical trial invoices.
• Assist in writing study documents, including protocols and informed consent forms.
• Ensure TMF setup, maintenance, and archiving in compliance with SOPs.
• Organize and participate in investigator meetings and site training sessions.
• Support quality audits and regulatory inspections as required.

Job Requirements

• Bachelor of Science (BS) degree required; advanced degree preferred.
• 6-7 years of experience in clinical operations or trial management.
• GCP certification and knowledge of US clinical trial regulations.
• Strong organizational and record-keeping skills.
• Ability to work independently and collaboratively in a matrixed team environment.
• Proficiency in managing budgets, timelines, and study trackers.
• Excellent communication skills and problem-solving abilities.
• Flexibility to adapt to a fast-paced work environment.