Clinical Trial Manager

Overview

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

 

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

 

We See You.

 

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

 

This position is reporting to the Director, Clinical Operations and is remote.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

 

Individual 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

Primary skills and knowledge required include, but are not limited to the following:

Preferred Qualifications

• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred
• Knowledgeable of current FDA and local IRBs regulatory require