Perceive Biotherapeutics, Inc. · 14 hours ago
Clinical Project Manager / Senior Clinical Project Manager
United States
Full-time
Remote
Mid, Senior Level
$165K/yr - $195K/yr
5+ years expPerceive Biotherapeutics is a clinical-stage company focused on developing breakthrough neuroprotective therapeutics in ophthalmology. The Clinical Project Manager will manage end-to-end clinical operations for Ph 1 and Ph 2 trials, ensuring compliance with regulations and fostering collaboration among clinical trial sites and vendors.
BiopharmaBiotechnologyLife ScienceTherapeutics
Responsibilities
This role is intended to ensure end-to-end clinical management, including trial set-up, enrollment, execution and cross-functional coordination with multiple clinical trial sites and vendors in global Ph 1 and Ph 2 trials, per established timelines
The CPM will be responsible for site, CRO and trial vendor management to ensure timely and high-quality clinical trial conduct, maintaining strong relationships between service providers and clinical trial sites, and for keeping management apprised of clinical progress against established milestones
This individual will help to set the standards for clinical operations performance and build the wider culture of accountability, collaboration and continuous improvement
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
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 mindset
Demonstrated leadership and team management skills
Demonstrated business acumen with strong understanding of sponsor business considerations
Preferred
Bachelor of Science degree required with a focus in a biomedical or related clinical field strongly preferred; advanced degree also 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