EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
EyeD Pharma is also offering surgical products to ophthalmologists who need products with the highest quality standards for their clinical practice.
To support its development, EyeD Pharma is hiring a Clinical Project Leader.
- Participates in strategic discussions regarding the design of clinical studies by working collaboratively with CMO and Core Teams members
- Develop and maintain 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
- Identifies risks for the successful conduct of the studies and implement solutions.
- Leads 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
- Ensures 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
- Master’s degree in Life Sciences, Nursing Licensure or Pharmacy or equivalent by experience
- 4 years of clinical operations experience as CPL; with responsibility in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
- Therapeutic experience in ophthalmology and/or medical device (preferred)
- Experience in early phase trials (Phase I-II) and First-In-Man trials (preferred)
- Ability to work within a team
- Ability to be productive and successful in an intense work environment, result oriented
- Excellent organization and project management skills
- Good negotiation and communication skills
- Read, write and speak fluent English
- Proactive and willing to work in a start-up environment.
- You share the values of integrity, team spirit and feel it is important to take care of your co-workers
EyeD Pharma offers
- A permanent position in an innovative and dynamic and fast growing company;
- Full time ;
Please send your CV and cover letter in English to : email@example.com.