Clinical Project Manager/ Senior Clinical Project Manager

Perceive Biotherapeutics is an exciting clinical-stage company focused on improving human health by developing breakthrough neuroprotective therapeutics in ophthalmology. They are seeking a Senior Clinical Project Manager to ensure end-to-end clinical management of Ph 1 and Ph 2 trials, including trial set-up, enrollment, and cross-functional coordination with multiple clinical trial sites and vendors.

Responsibilities:

• Manage defined aspects of clinical trials to ensure trials are completed on time and in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines and company SOPs
• Plan, coordinate and manage activities within various phases of clinical studies (i.e. study planning, site qualification and selection, study start-up, enrollment, monitoring, data review and cleaning, closeout, etc.)
• Contribute in development of essential study documents and develop, review/approve study specific operational documents, tools and tracker
• Provide Vendor Management and Oversight (participate in selection, qualification, contracting of clinical vendors, coordinate and/or lead vendor set-up and management activities)
• Build and maintain great working relationships with KOLs and PIs and extended site staff at clinical sites and participate in site interactions and management from identification through closeout
• Drive cross-functional collaboration with internal stakeholders to support timely and aligned trial execution
• Contribute to departmental process improvement initiatives and support the growth and mentorship of junior team members, where applicable

Requirements:

• Bachelor of Science degree required with a focus in a biomedical or related clinical field strongly preferred; advanced degree also preferred
• 3+ years of experience in clinical operations, with at least 2 years of direct clinical trial management experience at a sponsor or CRO required
• At least 5 years of experience in the clinical research / pharmaceutical / biotech / medical device industries
• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), and medical terminology
• Demonstrated ability to lead clinical projects to timelines and on budget, including detailed tracking, troubleshooting, and effective escalation with excellent planning and organizational skills
• Demonstrated success in working with outside organizations/groups/vendors/CROs
• Strong project management skills
• Excellent communication, negotiation, and stakeholder management skills
• Strong critical thinking, organizational, and problem-solving abilities
• Demonstrated track record of success working in remote or hybrid work environments
• High personal integrity, strong work ethic, accountability, and a solutions-oriented approach
• Demonstrated leadership and team management skills
• Demonstrated business acumen with strong understanding of sponsor business
• Experience with retina/ophthalmology and gene therapy strongly preferred
• Experience in a small, innovative company environment preferred
• Previous on-site monitoring experience is preferred