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EyePoint · 3 weeks ago

Senior Clinical Trial Manager

United States

Full-time

Remote

Senior Level

$146K/yr - $185K/yr

5+ years exp

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.

BiotechnologyHealth CareMedicalPharmaceutical

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

Qualification

ICH-GCP guidelinesClinical trial managementRegulatory complianceOphthalmology experienceGlobal clinical trial experienceProject management softwareFinancial budgetingAttention to detailCross-functional teamworkWritten communicationInterpersonal skills

Required

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

Preferred

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

EyePoint

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.

Founded in 1987

Watertown, Massachusetts, USA

51-200 employees