Clinical Project Manager

Job Description

Job Description

Do you have a passion for clinical research and project management? If yes, read on!

Join ONL Therapeutics as a Clinical Project Manager and play a key role in pioneering treatments that protect and restore vision!

About Us

ONL Therapeutics is a clinical-stage biopharmaceutical company committed to helping patients see the future. Our mission is to develop innovative therapeutics to protect and improve the vision of patients with a range of retinal diseases and conditions.

Headquartered in Ann Arbor, Michigan, the company is looking for dynamic self-starters to join the company. The company’s lead therapeutic candidate, ONL1204, is a first-in-class small peptide with a unique and differentiated mechanism of action.

By inhibiting the Fas receptor, ONL1204 effectively blocks the activation of the Fas pathway and the related immune signaling which results in the death of key retinal cells and loss of vision.

ONL’s lead compound ONL1204 Ophthalmic Solution is being studied across the following indications :

• A Phase 2 clinical study in patients with macula-off, rhegmatogenous retinal detachment. This US-based study is now complete with final CSR and closeout activities underway.
• A Phase 1b clinical study in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD).

This study conducted in Australia and New Zealand is now complete with final CSR and closeout activities underway.

• A Phase 1b clinical study in patients with open-angle glaucoma. This study conducted in Australia and New Zealand is now complete with final CSR and closeout underway.
• ONL is now preparing for a global Phase 2 study in GA to be launched in in 2024.

To learn more, please visit : https : / / www.onltherapeutics.com /

About the Role

ONL is looking for a full-time Clinical Project Manager (CPM) to join the team. The CPM Clinical Project Manager is accountable for the oversight of study conduct at clinical sites and will provide operational and management support to ensure delivery of assigned clinical programs and goals in accordance with regulations and ONL Quality Management Systems.

The assigned clinical programs may include all stages of development (from Phase 1 to Phase 3) in the areas of Geographic Atrophy, Glaucoma, Retinal Detachment, and other ophthalmic conditions.

The CPM assists with the implementation and management of the clinical project(s) from initiation to clinical report writing.

Programs may involve partial or full services provided by qualified Clinical Research Organizations (CROs). This position reports to the Director of Clinical Operations.

This is a full-time, on-site position located at the company’s Ann Arbor headquarters office. Occasional after hours work may be required due to global time zones.

Key Responsibilities :

• Provide clinical study expertise and support from study start-up to close-out in accordance with regulatory compliance
• Maintain projects within pre-defined timelines
• Collaborate with external vendors and partners on the following activities :
• Point of contact with study CRO for study start-up, conduct and close-out
• Responsible for coordinating the delivery of quality data and trial documents / records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures, Good Clinical Practice, and regulatory requirements
• Monitors site progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to leadership
• Actively participate in Investigator’s Meetings as trainer of selected topics
• Create and maintain project-related documents, plans, and processes; reassess and course-correct, as needed
• Perform site visits as needed
• Participate in ongoing review of study data
• Actively engage in teleconferences / meetings, including tracking and following-up on key action items
• Liaise with vendors participating in the program(s)
• Track study progress, invoices, and other project management tasks
• Escalation of issues to the CRO, Director of Clinical Operations and / or COO, as appropriate
• Organize in-house portions of clinical studies including, but not limited to :
• Planning the clinical study supplies necessary for project implementation
• Create and implements study-specific clinical monitoring tools and documents
• Assist with compiling and analysis of study data
• Tracking / management of study progress, payments, and other project tasks.

About You

• Bachelor’s degree in nursing or life sciences.
• 5+ years of work experience in clinical development / clinical trials
• Experience with various study systems (EDC, reading center portals, etc.) used in clinical trials
• Detail-oriented and meticulous in all aspects of work
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Professional demeanor and strong communication skills with the public as well as collaborators and physicians / researchers
• Self-starter with solid leadership skills, ability to work well independently as well as in team environment
• Possess the ability to work well under pressure, multi-task, be flexible, and manage deadlines
• Solid communication and computer skills required e.g., proficient in Microsoft Office Word, Powerpoint and Excel

Preferred experience, skills, knowledge and education :

• Master's Preferred
• Clinical site monitoring experience a plus
• Understanding and familiarity with ophthalmic diagnostic tests and equipment used at clinical sites preferred
• Early-stage biotech and ophthalmology experience a plus

Why work with us?

• Compensation includes salary, bonuses and stock options.
• Benefits include health, vision and dental insurance plans, 401(k), holidays and vacation.
• Hybrid schedule with the flexibility to WFH on Mondays and Fridays.

EEO Statement

ONL is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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