Senior Clinical Trial Manager

Role Summary

Senior Clinical Trial Manager. This remote role reports to the Associate Director, Clinical Operations. The role leads and oversees end-to-end clinical operations for EyePoint’s trials, ensuring quality, regulatory compliance, and on-time delivery through collaboration with CROs, vendors, and investigative sites. Location: Remote.

Responsibilities

• Key Clinical Operations role: ensures that delegated components of clinical trials are executed to expected and specified quality standards
• Expands knowledge of clinical trials operations and objectives of EyePoint’s trials under some direction; largely self-directed and capable of working independently while knowing when to involve others
• Builds best practices in clinical operations methodologies, systems and processes with emphasis on quality, timelines and expectations
• Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations
• Authors, reviews or contributes to clinical study documents
• Reviews and approves study-related plans generated by Clinical CROs and vendors
• Provides input as the subject matter expert for the study during regulatory inspections
• Executes the clinical study in accordance with the project clinical development strategy and timelines
• Contributes to the review of international study documents and local adaptation when necessary
• Responsible for timely clinical review/approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines
• Responsible for oversight of identification and selection of investigator sites
• Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments
• Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
• Collaborates with the cross functional team on selection and management of clinical vendors
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Trains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements
• Monitors the status of clinical data collection of assigned clinical studies
• Ensures preparation for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMPGDP standards
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
• Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required
• Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
• Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact
• Responsible for the availability and tracking all relevant study information/ study metrics
• Oversees the resolution of data quality issues
• Reviews correspondence and monitoring reports relating to the study
• Evaluates CRO and vendor performance for future work
• Provides periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requested
• Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable
• Requests and critically evaluates proposals and change orders from CROs and vendors
• Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities

Qualifications

• Required: Understanding of ICH-GCP guidelines, clinical trial monitoring, and regulatory compliance; knowledge of FDA and local IRB requirements; strong attention to detail; ability to work in a fast-paced environment; independently-minded with strong cross-functional collaboration and communication; proficiency with computer and project management software; familiarity with budgeting/forecasting or reporting; experience leading multiple clinical trials; 5+ years in clinical operations within pharma/CRO; at least 3 years as a Clinical Trial Manager / Project Manager; Bachelor's degree or nursing degree (scientific/healthcare field preferred but not required).
• Preferred: Ophthalmology experience; up to 20% travel (domestic/international); experience directing inspection readiness; global clinical trial experience and ability to lead/manage more than one trial; strong written and oral communication; ability to work independently and within cross-functional teams; attention to detail; strong interpersonal skills; familiarity with budgeting and forecasting; strong problem-solving and data quality oversight.

Education

• Bachelor's degree or nursing degree required; field in scientific/healthcare preferred.

Skills

• Excellent written and oral communication; strong interpersonal skills
• Ability to work independently and within cross-functional teams
• Strong project management and computer software proficiency; budgeting/forecasting experience
• Strategic thinking, problem solving, and attention to quality and timelines

Additional Requirements

• Up to 20% domestic and/or international travel may be required
• Periodic site/CRO visits to assess progress and protocol compliance