Perceive Biotherapeutics, Inc. · 1 month ago
Clinical Project Manager/ Senior Clinical Project Manager
US-CA-San Francisco
Full-time
Hybrid
Mid, Senior Level
$165K/yr - $195K/yr
5+ years expPerceive Biotherapeutics is an exciting clinical-stage company focused on 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, emphasizing quality, efficiency, and operational best practices.
BiopharmaBiotechnologyLife ScienceTherapeutics
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
Qualification
Required
Bachelor of Science degree required with a focus in a biomedical or related clinical field strongly 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
Preferred
Advanced degree preferred
Experience with retina/ophthalmology and gene therapy strongly preferred
Experience in a small, innovative company environment preferred
Previous on-site monitoring experience is preferred
Company
Perceive Biotherapeutics, Inc.
A start-up developing novel ophthalmic therapeutics to treat major unmet needs for patients.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$78M2023-01-05Series B· $78M
Leadership Team
Anne Rubin
President, Board Member and Co-Founder
Recent News
2023-12-22
Company data provided by crunchbase