Clinical Trial Manager

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.

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

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 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/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 the ability to lead/manage more than one clinical trial
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
• Ability to work independently and take initiatives.
• Ability to work/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 efficiency
• Excellent written and oral communication skills

Level of Education Required:

Bachelor's degree at least preferred in Scientific/health care related field.

Number of Years of Experience in the Function and in the Industry:

• 5+ years’ experience working in clinical operations within a pharmaceutical company or CRO or similar organization
• Experience of at least 1 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO preferred

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below.

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