[Hiring] Senior Clinical Trial Manager @EyePoint Pharmaceuticals, Inc.

Role Description

This position is reporting to the Associate Director, Clinical Operations and is remote.

• 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

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
• Ophthalmology experience strongly preferred
• Up to 20% domestic and/or international travel may be required
• Previous experience directing inspection readiness strongly preferred
• Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not 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 efficiency
• Excellent written and oral communication skills
• Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization

Requirements

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

Benefits

• 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 $146,260.00/Yr.
• Max: USD $184,713.00/Yr.