Clinical Project Leader

at  EyeD Pharma

Founded in 2012, EyeD Pharma is a clinical stage pharmaceutical company dedicated to improving the life of patients suffering from ophthalmic diseases with unmet medical needs such as glaucoma or dry eye. We develop innovative therapeutic solutions based on sustained release polymeric micro-implants and inserts.

• Participate in strategic discussions regarding the design of clinical studies by working collaboratively with CMO and Core Teams members
• Develop and maintain clinical study timelines and budget within the agreed plan and in case of deviation, put in place contingency plan
• Manage clinical study activities to meet enrolment targets according to projected timelines
• Identify risks for the successful conduct of the studies and implement solutions.
• Lead and manage clinical study activities, including but not limited to
• Lead preparation of all study-related documents (eg ICF, IB, Protocol, CRF, etc.)
• Lead study start-up process, including, vendor selection, site selection and finalization of site and vendor Clinical Trial Agreements, set-up of TMF
• Ensure efficient monitoring and follow-up of clinical activities subcontracted to third parties such as CRO
• Ensure effective study plans are in place
• Chair clinical study group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Ensure TMF completeness in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Ensure that study is conducted in compliance with study protocol, with ICH- GCP and that safety, right and well-being of patients are preserved
• Active contribution as per needs in Scientific advices, Advisory boards and scientific meetings