Clinical Trial Manager

EyePoint’s Clinical team drives the advancement of innovative therapies to improve the lives of patients living with serious retinal diseases. This team leads the design and execution of patient-centric clinical trials, managing robust safety and clinical data to produce high-quality, reliable insights that support regulatory and product development decisions. With a strong focus on safety, accessibility, and data integrity, the function helps accelerate the delivery of meaningful, vision-preserving treatments to patients.

About the role

A key Clinical Operations role ensuring delegated components of clinical trials are executed to expected and specified quality standards. Expands basic knowledge of clinical trials operations and scientific principles under some direction and guidance of senior staff but largely self-directed. Builds best practices in clinical operations methodologies, systems, and processes, with particular emphasis on quality and time standards. Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations. This position reports to the Director, Clinical Operations and is remote.

Responsibilities

• Authors, reviews, and 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) and is 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
• Plans and conducts investigator’s meetings in cooperation with the respective departments
• Ensures 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
• 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
• Performs 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 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 of 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 to ensure best practice across all activities

Requirements

• Bachelor’s degree at least preferred in a scientific/healthcare-related field
• 5+ years’ experience working in clinical operations within a pharmaceutical company, CRO, or similar organization
• Experience of at least 3 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO
• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred
• 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 is required (scientific/healthcare field preferred, but not required)
• Previous experience in Ophthalmology (clinical trial management, study coordination, COT, etc.)
• Global clinical trial experience and the 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 demonstrated ability to juggle multiple competing tasks and demands
• Ability to work independently and take initiative
• Ability to work and communicate successfully within a cross-functional team
• Strong knowledge of applicable computer and project management software packages
• Familiarity with financial budgeting and forecasting or reporting
• Respectfully challenges current practices, decisions, or ideas to promote quality and efficiencies
• Excellent written and oral communication skills
• Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization

Pay

The salary range for this position is $128,750 USD - $163,083 USD.

Benefits

• Transformational Innovation: Forward-looking, embracing challenges with curiosity, and continuously seeking to improve products and processes through learning and problem-solving.
• Unwavering Integrity: Recognizing responsibility to patients, employees, and the community, valuing trust, and setting a high ethical bar.
• Compassionate Excellence: Fostering a culture where enjoying work and caring for each other are as important as delivering exceptional outcomes.
• Inclusive Collaboration: Striving to see through the eyes of others, working as one team, and appreciating differences and perspectives to ensure everyone feels valued and respected.