Senior Project Management Specialist - Clinical Trial Operations
New
United StatesFull-TimeSenior
Salary95,000 - 110,000 USD per year
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Job Details
- Experience
- 3+ years
Requirements
- Bachelor’s degree in life sciences, health sciences, pharmacy, medicine, or a related field
- 3+ years of experience in clinical operations, medical affairs, or related roles within oncology, immunology, or regulated clinical environments
- Strong ability to interpret clinical trial protocols and apply them in operational settings while maintaining compliance
- Experience coordinating cross-functional stakeholders and managing complex, time-sensitive clinical projects
- Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities simultaneously
- Familiarity with project coordination methodologies and tools used in regulated clinical research settings
- Ability to work independently, take initiative, and respond quickly in high-pressure situations
- Preferred: experience in cell and gene therapy or advanced clinical development environments (e.g., TCR-T, TIL)
Responsibilities
- Coordinate and manage end-to-end patient journeys from informed consent through treatment and first clinical scan, ensuring timely and compliant progression.
- Lead regular site touchpoint calls, document updates, and drive clear next-step actions across clinical stakeholders.
- Collaborate with internal cross-functional teams to ensure consistent interpretation and execution of clinical trial protocols.
- Monitor and adapt patient workflows in real time based on site constraints, protocol requirements, and operational needs.
- Support critical milestones including eligibility review, randomization, and manufacturing timelines in coordination with internal teams.
- Guide sites on data entry requirements (e.g., EDC), resolve operational issues, and escalate deviations when needed.
- Maintain proactive communication with site personnel, serving as a responsive point of contact throughout the clinical process.
- Ensure alignment of all activities with regulatory standards and study-specific requirements within a Phase 3 environment.
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