France
Nicox S.A.
Drakkar 2 – Bât D
2405 route des Dolines – CS 10313
Sophia Antipolis – 06560 Valbonne
Tel: +33 (0)4 97 24 53 00
Nicox S.A.
Drakkar 2 – Bât D
2405 route des Dolines – CS 10313
Sophia Antipolis – 06560 Valbonne
Tel: +33 (0)4 97 24 53 00
Nicox Research Institute
Via Ludovico Ariosto, 21
20091 Bresso, Milano
Tel: +39 02 61036 1
Nicox Ophthalmics, Inc.
4819 Emperor Blvd. Suite 400
Durham, NC 27703
Tel: +1 984 219 1751
Nicox S.A. is the parent company of the Nicox Group and is based in France. The HQ is the corporate center of the company, with the Finance, Legal, Corporate Development and Communications & Investor relations Departments. Nicox S.A. has two international subsidiaries, one in North Carolina, in the United States, focused on development, and the other in Milan, Italy focused on research and nonclinical development.
The Nicox Research Institute in Milan is the Research and Nonclinical Development Center of the Company, with a team of scientists with significant expertise in the synthesis and biological testing of nitric oxide (NO)-donating molecules and in the early development of new molecular entities. The group works through collaborations with high-quality contract research organizations and universities throughout the world, and also manages the extensive Nicox patent portfolio.
Nicox Ophthalmics, Inc. in Durham, NC, is the therapeutic development subsidiary of the Company in which our Development Team has an in-depth experience in Chemistry, Manufacturing and Controls (CMC) and clinical development, with a strong focus in ophthalmology. They work with experienced and leading contract manufacturing and clinical research organizations to conduct our clinical studies.
We’re always eager to meet fresh talent, so check out our open positions.
Manage clinical studies, according to ICH-GCP and local regulations, maintain projects within pre-defined timelines and budget and evaluate and/or propose study resource allocations within Nicox
Manage study specific trainings within Nicox
Ensure the quality of study data
Manage CRO(s) including:
Active participation in CRO selection
Primary point of contact with study CRO and overall supervision of CRO activities of assigned projects
Set up and initiation of clinical studies from Phase 1 to 3
Attending and participating in Investigator’s Meetings as trainer of selected topics
Review, finalization and authorization (if appropriate) of CRO project-related documents
Performing site visits (co-monitoring or alone)
Participation in ongoing review of study data with focus on protocol deviations
Participation in Nicox-CRO(s) teleconferences/meetings
Liaising with vendors participating in the programs
Tracking of study progress, invoices, and other project management tasks
Escalation of issues to the VP and Head of Clinical Development and/or Chief Scientific Officer, as appropriate
Review of Statistical Analysis Plan, draft and final Tables, Figures and Listings
Participation in and organization and review of the Clinical Study Report
Review audit reports and respond or take necessary actions to resolve any issues raised
Organize in-house portions of clinical studies including:
Planning the clinical study supplies necessary for project implementation, in co- operation with Pharmaceutical Development
Tracking/management of study progress, payments, and other project tasks.
Managing information flow/communication with all relevant groups to ensure smooth running of the projects
Manage in-house CRA’s and CTA’s project related activities (if applicable)
Participate in the recruitment, selection and training of in-house clinical staff
Participate in study design and writing of protocols
Participate in development of clinical procedures and propose necessary procedures writing of the SOPs, as appropriate
Actively participate on the Project teams
To back up other Team members in case of absence, travel, etc., if and when applicable.
M.S. preferred
Five (5) plus years of experience on Clinical Research in Ophthalmology preferably in the areas of glaucoma, and dry eye
Certified training in GCP
Advanced proficiency in Microsoft Office Programs (Outlook, Excel, Word, Access, Project, PowerPoint) and able to function remotely from local network.
Exceptional interpersonal, organizational, time management, and communication (verbal and written)
Outstanding communication skills, both verbal and written in English. Spanish is a plus.
Detailed understanding and familiarity with ophthalmic diagnostic tests and equipment used at clinical sites.
Experience with various study systems (InForm, MediData, Perceptive, Trident, reading center portals, etc.) used in clinical trials
Excellent organization skills and ability to multi-task.
Travel to CRO(s) and clinical sites as necessary is required in the US and infrequent travel (once or twice a year) outside US as needed.
Valid driver’s license.
To be successful in this role, the candidate needs to ensure the project meets the corporate goals on time. Top candidates are proficient multi-taskers with an ability to prioritize tasks.
Applications, with CV and covering letter, to Valentina Chiarelli, HR Manager, chiarelli@nicox.com.