Offer summary

Qualifications:

Bachelor’s degree in Life Sciences or related field preferred., Minimum 7 years of clinical data management experience required., Extensive experience managing global studies utilizing an outsourced CDM model., Knowledge of regulatory requirements for clinical data systems including 21 CFR Part 11..

Key responsabilities:

Participate in cross-functional leadership teams representing Data Management.

Manage assigned studies/projects and make expert recommendations to ensure timelines and deliverables.

Oversee execution of all data management activities in support of clinical studies with CROs.

Collaborate with Clinical Operations and Quality Assurance to ensure data integrity and compliance.

Job description

Overview:

Be Seen and Heard at EyePoint

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
transforming ocular drug delivery

We See You.

Your wellbeing
Your professional worth
Your future at EyePoint

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.

This position is reporting to the Sr. Director, Data Management. This role will be remote.

This role is responsible for CRO oversight regarding the Data Management responsibilities.

Responsibilities:

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

Participate in cross functional-area leadership teams representing Data Management.
Manage the assigned studies/project and makes 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.

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

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.

Level of Education Required:

Bachelor’s degree in Life Sciences or related field preferred.
Ophthalmology experience preferred.

Number of Years of Experience in the Function and in the Industry:

Minimum 7 years of clinical data management experience required

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

#LI-Remote

Required profile