Sr. Clinical Trial Manager/Clinical Trial Manager

About Eyenovia

Eyenovia, Inc. (NASDAQ: EYEN), is a commercial-stage ophthalmic technology company preparing for the launch of Mydcombi™ (tropicamide phenylephrine ophthalmic spray for mydriasis) and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications. For more Information, visit www.eyenovia.com.

Position Description

Position Title: Senior Clinical Trial Manager/Clinical Trial Manager, New York City On-Site

Department: Clinical Operations and Medical Affairs

FLSA Status: Exempt

Scope of Job

Job Summary:

The Clinical Trial Manager has responsibility for the set-up, implementation and completion of clinical study protocols performed under Eyenovia’s clinical development programs in accordance with corporate-defined timeframes and budgets as well as applicable regulations. This responsibility includes identification, qualification and contracting of clinical study investigational sites, protocol and procedural training, study monitoring, site management, and trial master file management. The Senior Clinical Trial Manager will train and supervise the work of personnel completing clinical study related activities.

Receives Direction From:

Vice President, Clinical Program Strategy and Development

Provides Direction To (as appropriate):

· Clinical Research Associates

· Contract Research Organizations

· Study Vendors

Essential Functions

Preference will be given to candidates with experience authoring clinical documents (protocols/study reports/development plans).

Essential functions include, but are not limited to the following:

The Senior Clinical Trial Manager will perform the following activities for assigned studies:

· Provide operational input and coordinates the development of clinical study protocols, data collection forms, study informed consent documents and other essential study documents.

· Identifies clinical study investigational sites and manages associated evaluation and qualification activities as well as personnel completing the activities.

· Develops and creates study-specific support documents and tools, such as site budgets, monitoring plans and guidelines, study guidelines, study trackers, site/CRA training materials, etc.

· Manages development and implementation of study patient recruitment strategies and tactics.

· Develops and presents Study Coordinator and Investigator Meeting materials.

· Oversees set-up and maintenance of study regulatory files.

· Plans, implements and manages site start-up activities to optimize performance in accordance with corporate goals.

· Negotiates/implements clinical trial and financial agreements with study sites.

· Manages preparation and submission of study documentation require to support registration and approval of study protocols and study sites by Institutional Review Boards (IRB) or Ethics Committees (EC)

· Identifies and interfaces with study vendors (equipment suppliers, CRO, contract monitors, etc.) to negotiate/implement work agreements and coordinate delivery of requested services.

· Ensures ongoing tracking and reporting of important study metrics are completed in a timely manner to meet corporate milestones (e.g., subject screening/enrollment/treatments, follow-up visit compliance, queries/subject/CRA, etc.)

· Manages necessary site visit activities with regional and in-house CRAs, reviews site monitoring visit reports in a timely fashion and follows up as necessary with study team and/or sites regarding outstanding issues.

· Coordinates site study supply inventory, including investigational product requests and product accountability.

· Coordinates in-house clinical data review and query generation/resolution activities with data management.

· Manages ongoing study monitoring and site management activities to facilitate study performance in accordance with study protocols, GCP and federal/local requirements.

· Manages monitoring and site management activities associated with study close-out.

· Assists data management personnel with activities associated with database lock and clinical study data analyses and provides study-specific input to the preparation of clinical study reports as directed.

· Develops tracking and documentation of clinical investigational material before, during and after the study (ies)

Secondary Functions

To include, but are not limited to the following:

· Developing and maintaining departmental standard operating procedures in accordance with GCP and federal/local regulatory requirements.

· Perform site qualification, study initiation, routine monitoring, and study close-out visits and prepare monitoring visit reports and other related documents in association with visits.

· Assists data management personnel with clinical study database development and validation activities, as well as ongoing data management processes as directed by clinical operations management.

· Provides backup and support for the site payment activities.

· Assists with preparation of study safety narratives for review and approval by study Medical Monitor.

· Reviews and confirms clinical documents added to electronic trial master file are complete, accurate, and appropriately finalized and categorized.

· This position requires moderate travel.

QUALIFICATIONS GUIDELINES

To include, but are not limited to the following:

Education/Training/Experience

· BS/BA required. MS preferred. Education in biological or health sciences, with direct clinical experience preferred. Ophthalmology experience preferred.

· 5+ years’ experience in pharmaceutical industry clinical operations (e.g., study monitoring and study management). Experience with ophthalmic pharmaceuticals and medical devices is a plus.

· 1+ year direct supervisory experience

Knowledge/Skills/Abilities

· High attention to detail and excellent organization skills

· Self-starting and self-monitoring - ability to work with minimal direct supervision to complete tasks on time.

· Team player

· Knowledge and experience with ophthalmic products and equipment/instrumentation, along with familiarity with their use, technologies involved and risk management techniques as appropriate for the nature of the job.

· Knowledge of ICH E6: Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), and applicable FDA guidance documents associated with clinical trials. Should have knowledge of techniques for best practices implementation.

· Excellent critical thinking and problem-solving skills

· Excellent written and verbal communication skills

· Ability to schedule activities in a timely fashion.

· Ability to positively motivate others to achieve desired results.

· General understanding of ophthalmic terminology, clinical testing methods and disease states

· Excellent working knowledge of MS Word, MS PowerPoint, MS Excel

Physical Requirements

· Able to stand, walk and sit for extended periods of time.

· Able to travel by air, rail, car up to 40% of the time.

· Able to operate personal computer.

· Able to perform light lifting.

Training Requirements

Training in relation to company systems and procedures, as well as individual job duties will be provided by Eyenovia. The need for additional external training with respect to regulations, industry standards, etc. will be determined by employee’s supervisor, and provided as appropriate.

A file documenting employee training is maintained for each Eyenovia, Inc. employee.

Job descriptions change from time to time. The company retains the right, at its sole discretion, to modify information contained in this job description. Changes in job description will be discussed with the employee at or before implementation.

Eyenovia (NASDAQ:EYEN) is an equal opportunity employer. Eyenovia offers a competitive compensation package including medical/dental/vision, matching 401K, paid time off, holidays, and equity.