Senior 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 Associate 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
• 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 (e.g study protocol, ICF, etc.) and responsible for their 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’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 p