[Remote] Senior Clinical Trial Manager

Note: The job is a remote job and is open to candidates in USA. EyePoint is an ophthalmology company committed to preventing blindness through innovative therapeutics. The Senior Clinical Trial Manager will oversee the execution of clinical trials, ensuring quality standards are met and collaborating with various stakeholders to manage study processes effectively. 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 pharmaceutical regulations in order to ensure best practice across all activities Skills • Bachelor's degree or nursing degree is required • 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 • 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/communicate successfully within a cross-functional team • Strong knowledge of applicable computer and project management software packages • Excellent written and oral communication skills • Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization • 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 • Ophthalmology experience strongly preferred • Up to 20% domestic and/or international travel may be required • Previous experience directing inspection readiness strongly preferred • Global clinical trial experience and the ability to lead/manage more than one clinical trial • Familiarity with financial budgeting and forecasting or reporting • Respectfully challenges current practices, decisions, or ideas to promote quality and efficiency Company Overview • EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases. It was founded in 1987, and is headquartered in Watertown, Massachusetts, USA, with a workforce of 51-200 employees. Its website is Apply tot his job