Senior Clinical Trial Manager

Role Summary

Senior Clinical Trial Manager. Remote position reporting to the Associate Director, Clinical Operations.

Responsibilities

• Key Clinical Operations role: ensures that delegated components of clinical trials are executed to expected and specified quality standards
• Expands basic knowledge of clinical trials operations and scientific principles and objectives of EyePoint‚Äôs clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
• Buil ds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations
• Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations
• Authors/ reviews/ 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
• Accountable for the timely clinical review and/or 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‚Äôs 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 with management and other R&D functions
• Anticipates potential study issues and prepares contingency plans with minimal oversight
• Trains and manages CRO and other clinical vendor activities to ensure quality meets EyePoint and regulatory requirements
• Monitors the status of clinical data collection of assigned clinical studies
• Prepares for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMP/GDP 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
• Evaluates site and study performance metrics against budget, deliverables and timelines
• Oversees the management of clinical studies ensuring they are conducted in accordance with approved study plans
• Responsible for the availability and tracking of all relevant study information/ 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
• 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 to ensure best practice across all activities

Qualifications

• Understanding of ICH-GCP guidelines, clinical trial monitoring, and regulatory compliance; knowledge of FDA and local IRB requirements
• Ophthalmology experience strongly preferred
• Up to 20% domestic/international travel may be required
• Experience directing inspection readiness strongly preferred
• Bachelor‚Äôs degree or nursing degree required; scientific/healthcare field preferred
• Global clinical trial experience and ability to lead/manage more than one trial
• Strong attention to detail, prioritization, scheduling, and deadlines
• Ability to work in a fast-paced environment with multiple tasks
• Ability to work independently and take initiative
• Ability to work and communicate within a cross-functional team
• Strong knowledge of project management software and computer tools
• Familiarity with budgeting, forecasting, or reporting
• Willingness to challenge practices to promote quality and efficiency
• Excellent written and oral communication skills
• Strong interpersonal skills to interact with investigators, vendors, and stakeholders

Education

• Bachelor's degree in scientific/healthcare field preferred

Experience

• 5+ years in clinical operations within a pharmaceutical company or CRO
• At least 3 years as a Clinical Trial Manager/Project Manager or similar role