Clinical Project Manager/ Senior Clinical Project Manager

Overview

Perceive Biotherapeutics is an exciting clinical-stage company (lead program in Phase 2), focused

on improving human health by developing breakthrough neuroprotective therapeutics in

ophthalmology that use novel approaches to treat highly prevalent, blinding diseases that

currently have no good therapeutic alternatives. Perceive brings together an experienced, worldclass

team of leaders, scientists and drug developers. Our unique approach is a first-in-class and

best-in-class gene therapy that will significantly impact patients’ lives. Our team is mission driven,

expert, agile and pragmatic.

We are looking for a talented and experienced individual to join our growing Clinical Operations

team and contribute to the company’s long-term goals and success. The successful candidate will

be diversely experienced, thoughtful, collaborative, highly motivated & productive, and possess

the desire to learn, improve processes, and support key clinical stakeholders during our Ph 1 and

Ph 2 trials with an emphasis towards quality, efficiency and operational best practices.

Responsibilities

Context and Job Duties/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. A successful

candidate in this role will quickly determine and address needs along these lines:

• 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.

Travel: Up to 20% travel may be requested for site engagement and internal meetings. These

may include multi-day international trips. Position is remote Pacific Time zone work hours is

strongly preferred.

Qualifications

Education, Experience, Capabilities and Knowledge:

A successful candidate for this role is an expert in all aspects of pharmaceutical clinical research

and the requirements of the clinical operations function. The successful candidate also

thoroughly understands early, mid and late-stage trial performance, forecasting, staffing, and

business operations. Qualifications include:

• 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.
• Experience with retina/ophthalmology and gene therapy strongly preferred.
• Experience in a small, innovative company environment preferred.
• Previous on-site monitoring experience is preferred.
• Proven ability to drive timelines, quality, and compliance across multiple vendors and
•  

Trainings and Skills

• 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
•  
• Demonstrated leadership and team management skills.
• Demonstrated business acumen with strong understanding of sponsor business
•  

Location

This is a remote position.

Targeted annual pay band is $165,000-195,000 with some flexibility commensurate with experience.

Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and

applicants for employment without regard to religion, race, creed, color, sex, sexual orientation,

alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran

or military status, predisposing genetic characteristics or any other characteristic protected by

applicable federal, state or local law.

Please note that Perceive Bio will only collect personal information using a legitimate company

email domain and will never offer payment or any financial transaction over text or email. Always

verify that emails or other communications are directly from perceivebio.com.

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Salary : $165,000 - $195,000