Clinical Data Assistant Jobs in Wisconsin (NOW HIRING)

Clinical team at EyePoint drives the advancement of innovative therapies to help improve the lives of patients living with serious retinal diseases. This team leads the design and execution of patient-centric clinical trials, while managing robust safety and clinical data to produce high-quality, reliable insights that support regulatory and product development decisions. With a strong focus on safety, accessibility, and data integrity, the function helps accelerate the delivery of meaningful, vision-preserving treatments to patients.

This role is reporting to the Chief Medical Officer and is remote.

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

• Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio.
• Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs.
• Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
• Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials.
• Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
• Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
• Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
• Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations.
• Assist with study milestones and study metrics in collaboration with clinical operations.
• Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines.

• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
• Experience in ophthalmology and familiarity with drug/device combination products
• Experience with all phases of clinical drug development including regulatory submissions
• Ability to survey and interpret scientific literature related to the assigned portfolio of products
• Strong communication, organizational and interpersonal skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Independent decision‑making and analytical skills are required.

Advanced degree in life science/clinical/medical field, PhD or PharmD

Minimum of 10 years of clinical development/research and R&D experience preferred.

$197,760 - $249,947 USD

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed topreventing blindnessby developing and commercializing innovative therapeutics.

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

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.

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.

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.

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.

EyePointis 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.