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Clinical Project Management Associate
2 months ago
Job Summary:
Ocular Therapeutix is seeking a highly skilled Clinical Project Management Associate to support the execution and coordination of clinical studies in the field of ophthalmology. This is a 6-month contract role.
Key Responsibilities:
- Coordinate the activities of the clinical trial team and manage project information and communications to all stakeholders throughout the lifecycle of drug development.
- Assist in the management, execution, and oversight of assigned studies, ensuring high-quality standards are met.
- Maintain a task ownership matrix to document internal and external stakeholders' responsibilities.
- Coordinate the development and review of study documents, including protocols, informed consent forms, and clinical study reports.
- Conduct quality control tasks, such as TMF review and document verification.
- Identify, select, and manage vendors, including the management of applicable documentation and systems.
- Represent clinical operations at project team and cross-functional meetings, ensuring effective communication and collaboration.
- Document meetings and maintain study timelines, budgets, and other trackers.
- Ensure study training is documented for all study team members.
- Document study-specific decisions, actions, issues, and risks throughout the study lifecycle.
- Maintain data in assigned systems and perform other duties as required.
- Conduct quality oversight and site engagement visits as needed.
Qualification Requirements:
- Bachelor's degree in a health-related field or science.
- A minimum of 5 years of experience in the medical device or pharmaceutical industry, including 3 years of relevant clinical research experience.
- Ophthalmology experience is required.
- Some monitoring experience is preferred.
- Excellent written and oral communication skills.
- Computer literacy and proficiency in MS Office suite, TEAMS, and SharePoint.
- Excellent organizational skills and attention to detail.
- Ability to work virtually and travel approximately 35% for educational seminars, on-site study oversight, and site engagement visits.
