Clinical Project Manager I
Clinical Research IO (CRIO)About the role
CRIO has historically sold a full-stack solution to clinical research sites, the centerpiece of which is the industry’s leading eSource solution. CRIO’s built-in client site network now spans 2000 sites worldwide, and on some trials CRIO’s sites comprise as much as 30% of the U.S. sites on the trial. These sites are high-enrolling, tech-forward sites who use CRIO intensively across their core processes. With this large site network and a proven direct data capture solution in place that reduces protocol deviations by 40% and audit risk by 70%, CRIO has delivered quality and efficiency gains on thousands of trials. Recently, CRIO developed and launched a separate application called Reviewer that aggregates anonymized study level data captured in eSource for sponsor/CRO review. This process enables immediate, continuous (not periodic), remote and centralized monitoring across the study, and eliminates the need for (a) site entry into the EDC, (b) SDV by the monitor, and (c) form by form review by Data Management.
CRIO’s strategy is to target small to medium sized biotech and pharma sponsors with a delivery model that ensures higher quality data, faster time to lock, rapid site startup, greater incentivization of the sites, and more reliable enrollment timelines, at a reduced overall cost. To execute this, CRIO is seeking an experienced senior resource with CRO experience to reimagine the clinical trial delivery process for sponsors centered around CRIO’s innovative site-centric approach.
Requirements
- Ensure quality, speed, and cost savings in delivering our core promises to new and existing clients
- Help drive the product roadmap to enhance efficiency, including vendor integrations with clients
- Assist in managing and assessing vendors to integrate into CRIO’s end-to-end workflow vision.
- Commercialize CRIO technology by articulating delivery solutions to sponsors and CROs.
- Establish a self-service study delivery model for in-house sponsor trials.
- Assist with the CRO channel program, certifying and partnering with CROs for successful CRIO technology delivery.
- Help to optimize our strategy for CRIO site selection, offering a paid service to identify optimal clinical trial sites using client data.
- Collaborate with sales and marketing to promote the new vision to sponsors via speakerships, case studies, and written pieces.
- Assist with the development of a Clinical Trial Delivery Program
- Help create a comprehensive implementation plan for both sponsors and CROs.
- Create ongoing and essential SOPs aligned with CRIO technology.
- Maintain service level targets to meet quality and efficiency objectives for sponsors.
- Contribute to the RFP process by defining the support program for success.
- Help to identify vendors needed for end-to-end tech stack and establish strategic relationships for integrations.
Secondary Responsibilities:
- Foster team collaboration by exploring new opportunities and supporting colleagues to accomplish results.
- Maintain technical knowledge by attending training and staying updated on industry trends.
Qualifications:
- Education: Bachelor’s degree in life sciences, pharmacy, nursing, or equivalent; Master’s degree preferred.
- Experience: 1-3 years of previous management or project experience in clinical development require or
- 1-3 years of clinical trials experience within a CRO or pharmaceutical research organization.
- Working knowledge of GCPs, ICH guidelines, FDA regulations, and EDC/eSource/DDC systems.
- Additional Skills: Strong communication, organizational, leadership, and problem-solving abilities.
Benefits
- Work from anywhere
- Co-working Reimbursement
- Lunch on us - During Training Days
- Unlimited vacation
- Unlimited sick days
- 401k company match
- Healthcare
- Dental
- Vision
- Life insurance
- Professional development
This is an exciting opportunity to join a forward-thinking company with a transformative vision. We seek an individual committed to reshaping enterprise strategies and sharing our vision for a smarter, more effective approach to clinical trials.
Apply now to drive change and innovation in the industry!
(Please be advised that we do not currently provide visa sponsorship for this position. Candidates must possess the legal right to work in the United States without the need for sponsorship.)
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