Clinical Trial Manager

Be Seen and Heard at EyePointAt 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 Forpreventing blindness through vision-saving medicationsdelivering best-in-class proprietary pharmaceutical technologiestransforming ocular drug deliveryWe See You.Your wellbeingYour professional worthYour future at EyePointEyePoint 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.ResponsibilitiesPrimary responsibilities include, but are not limited to, the following:Individual ResponsibilitiesKey Clinical Operations role; ensures that delegated components of clinical trials are executed to expected and specified quality standardsExpands 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 othersBuilds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectationsManages study processes or efforts under the supervision of the Associate Director of Clinical OperationsProvide direct support to senior Clinical Operations team on day-to-day operational and tactical study activitiesReview/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 guidelinesManage 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 strategiesEnsure the delivery of clinical trial supplies in collaboration with the clinical supply teamCollaborate with the cross functional team on selection and management of clinical vendorsManages escalation of study related issues and communicates as appropriate with management and other R&D functionsAssist with audit readiness and study-related materialsAbility to anticipate potential study issues and to prepare contingency plans with minimal oversightMonitor the status of clinical data collection of assigned clinical studies and oversee the resolution of data quality issuesEvaluate site and study performance metrics against agreed upon budget, deliverables and timelinesServe as a point of contact for external partnersOversee 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 contactServe as the primary manager of unmasked responsibilities internally and with vendors Implement strong controls and procedures to mitigate potential issues related to unmaskingAssist with tracking project timelines, budgets, and invoice reviews Responsible for the availability and tracking of all relevant study information/ study metricsReview correspondence and monitoring reports relating to the studyEvaluate CRO and vendor performance for future workProvide periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requestedReview site budgets and contracts with CROs, vendors, and investigative sites, as applicableMaintain knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activitiesQualificationsPrimary skills and knowledge required include, but are not limited to the following:Preferred QualificationsUnderstanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferredKnowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research.Up to 20% domestic and/or international travel may be requiredBachelor's degree or nursing degree is required. Scientific/health care field preferred, but not requiredPrevious experience in an unmasked role in the conduct of clinical trials strongly preferredPrevious experience in Ophthalmology - clinical trial management, study coordination, COT, etc.Global clinical trial experience and the ability to lead/manage more than one clinical trialRequires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlinesMust be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demandsAbility to work independently and take initiatives.Ability to work/communicate successfully within a cross-functional teamStrong knowledge of applicable computer and project management software packagesFamiliarity with financial budgeting and forecasting or reportingRespectfully challenges current practices, decisions, or ideas to promote quality and efficiencyExcellent written and oral communication skillsLevel Of Education RequiredBachelor'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 organizationExperience of at least 1 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO preferredEnvision Your FutureWith 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 InnovationWe 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 IntegrityWe 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 ExcellenceWe 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 CollaborationWe 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 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. Min USD $128,750.00/Yr. Max USD $163,083.00/Yr.