Senior Clinical Trial Manager

Overview

Be Seen and Heard at EyePoint Pharmaceuticals

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.

General Job Description

• 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 VP of Clinical Operations

This position is located at our Watertown, MA site. We offer a hybrid work schedule.

Responsibilities

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

• 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
• Contribute 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
• 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 pharmaceutical regulations in order to ensure best practice across all activities

Qualifications

Level of Education Required/Preferred Field of Study:

• Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required

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 3 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO
• Ophthalmology experience

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
• 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 initiative
• 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 efficiencies
• Excellent written and oral communication skills
• Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization

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.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint Pharmaceuticals 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.

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