Clinical Trial Manager

Role Summary

Clinical Trial Manager. Remote position reporting to the 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’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
• Builds 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
• Provide direct support to senior Clinical Operations team on day-to-day operational and tactical study activities
• Review/contribute to clinical study documents and study related plans generated by Clinical CROs and vendors
• 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
• Manage TMF completeness and inspection readiness
• Support the team's adherence to oversight plans and contribute to internal audits and corrective action plans (CAPA)
• Help identify potential project risks and assist in developing mitigation strategies
• Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
• Collaborate 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
• Assist with audit readiness and study-related materials
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Monitor the status of clinical data collection of assigned clinical studies and oversee the resolution of data quality issues
• Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
• Serve as a point of contact for external partners
• Oversee 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
• Serve as the primary manager of unmasked responsibilities internally and with vendors
• Implement strong controls and procedures to mitigate potential issues related to unmasking
• Assist with tracking project timelines, budgets, and invoice reviews
• Responsible for the availability and tracking of all relevant study information/ study metrics
• Review correspondence and monitoring reports relating to the study
• Evaluate CRO and vendor performance for future work
• Provide periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requested
• Review site budgets and contracts with CROs, vendors, and investigative sites, as applicable
• Maintain knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities

Qualifications

• Preferred: Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance
• Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research
• Up to 20% domestic and/or international travel may be required
• Bachelor’s degree or nursing degree required; scientific/health care field preferred but not required
• Previous experience in an unmasked role in the conduct of clinical trials strongly preferred
• Previous experience in Ophthalmology - clinical trial management, study coordination, COT, etc.
• Global clinical trial experience and ability to lead/manage more than one clinical trial
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Ability to work in a fast-paced environment with multiple competing tasks and demands
• Ability to work independently and take initiative
• Ability to work/communicate successfully within a cross-functional team
• Strong knowledge of computer and project management software; familiarity with budgeting and forecasting or reporting
• Willingness to respectfully challenge current practices to promote quality and efficiency
• Excellent written and oral communication skills

Education

• Bachelor's degree in a scientific/health care related field preferred

Experience

• 5+ years’ experience in clinical operations within a pharmaceutical company or CRO or similar organization
• At least 1 year as a Clinical Trial Manager/Project Manager or similar role preferred