Associate Director, Data Management

EyePoint Pharmaceuticals, Inc.

96d • $150,000 - $195,700

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 Sr. Director, Data Management. This role will be remote and is responsible for CRO oversight regarding the Data Management responsibilities.

Requirements

• Extensive experience managing global studies utilizing an outsourced CDM model from start-up through close-out.
• Great communications skills, both verbal and written, remotely and in-person.
• Organized and detail-oriented for improving data management processes.
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11.
• Experience working Medidata Rave EDC systems.
• Ability to work independently and as part of a multi-disciplinary team.
• Highly motivated and flexible, with excellent organizational skills.

Nice To Haves

• Ophthalmology experience preferred.

Responsibilities

• Participate in cross functional-area leadership teams representing Data Management.
• Manage the assigned studies/project and make expert recommendations and/or decisions to the study teams that assure timelines and deliverables of the studies.
• Collaborate cross-functionally to resolve clinical data issues and ensure effective communication and leadership for strategic alignment throughout the drug development process.
• Oversee the successful execution of all data management activities in support of EyePoint clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving.
• Resolve and/or escalate issues encountered in study operation and improve the performance of the data management function.
• Provide the highest level of CRO/vendor oversight and is responsible for the studies to ensure requirements are met and the project plans are executed to meet the development needs.
• Leverage data management and related expertise to promote best practices across the drug development lifecycle and enhance collaboration with relevant stakeholders.
• Collaborate with Clinical Operations and Quality Assurance to certify the integrity and traceability of all clinical data sources, compliant with 21 CFR Part 11 standards.

Benefits

• Competitive salary range of USD $150,000.00 to $195,700.00 per year.
• Robust total rewards in a science-based entrepreneurial culture.
• Opportunities for professional development and career advancement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees