Clinical Trial Manager

EyePoint Pharmaceuticals, Inc.

93d • $128,750 - $163,083

About The Position

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, and transforming ocular drug delivery. This position is reporting to the Director, Clinical Operations and is remote. 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.

Requirements

• 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.
• Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required.
• 5+ years’ experience working in clinical operations within a pharmaceutical company or CRO or similar organization.
• Experience of at least 1 year as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO preferred.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Ability to work independently and take initiatives.
• 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.
• Excellent written and oral communication skills.

Nice To Haves

• Previous experience in an unmasked role in the conduct of clinical trials strongly preferred.
• Previous experience in Ophthalmology - clinical trial management, study coordination, COT, etc.
• Global clinical trial experience and the ability to lead/manage more than one clinical trial.

Responsibilities

• 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.
• 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.
• Provides direct support to senior Clinical Operations team on day-to-day operational and tactical study activities.
• Reviews/contributes 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 guidelines.
• Manages TMF completeness and inspection readiness.
• Supports the team's adherence to oversight plans and contributes to internal audits and corrective action plans (CAPA).
• Helps identify potential project risks and assists in developing mitigation strategies.
• Ensures 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.
• Assists with audit readiness and study-related materials.
• Monitors the status of clinical data collection of assigned clinical studies and oversees the resolution of data quality issues.
• Evaluates site and study performance metrics against agreed upon budget, deliverables and timelines.
• Serves as a point of contact for external partners.
• Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans.
• Implements strong controls and procedures to mitigate potential issues related to unmasking.
• Assists with tracking project timelines, budgets, and invoice reviews.
• Responsible for the availability and tracking of all relevant study information/study metrics.
• 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 site budgets and contracts with CROs, vendors, and investigative sites, as applicable.
• Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Benefits

• Competitive salary range of USD $128,750.00 to $163,083.00 per year.
• Robust total rewards package.
• Opportunities for professional development and career growth.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees