Study Design - Quality Control Manager - Clinical Trials

CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture. Our modules allow sites to capture data electronically in real-time, providing data managers and monitors with enhanced transparency, and enabling remote monitoring by sponsors and CROs.

CRIO’s eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO’s launch in 2016, CRIO has established the leading brand position in eSource and has won close to 50% of the emerging class of enterprise-grade site networks, many of whom are backed by institutional investors such as VC, PE and corporations. CRIO has achieved the attached metrics, all with little to no serious outbound sales or marketing.

In 2022, CRIO released its Reviewer product, a separate application that allows third parties to review, query, lock, medical code and extract source data collected in eSource. Reviewer is a flexible application that CRIO plans to commercialize with its own site networks, with third party vendors (e.g., overnight EDC entry services), and with sponsors and CRO’s as either a remote monitoring tool OR a full EDC solution. This innovative architecture is truly groundbreaking, and offers a new vision for how sponsors and CRO’s can drive quality and efficiency.

Quality Control Manager

We are seeking a highly motivated and skilled Quality Control Manager to join our dynamic team. In this role, you will thoroughly examine study design builds to ensure they align with the protocol requirements, regulatory guidelines, and industry standards. Your finely honed skills will detect and document any discrepancies, errors, or inconsistencies within the builds. Collaboration is key, as you will work closely with other Study Design Team members, Customer Success Managers, and Implementation Managers to ensure project deadlines are met. Additionally, you will play a pivotal role in providing training, education, and feedback to new hires and clients. Your collaboration with the Director of Study Design will aid in process improvement and the implementation of workflow measures to enhance efficiency.

Requirements

Key Responsibilities:

• Verify the accuracy and completeness of data fields, forms, and templates within the software.
• Maintain detailed records of review findings, including identified issues, resolutions, and any additional recommendations. Generate comprehensive reports to summarize the results of the review process.
• Monitor and analyze quality control metrics, and adjust quality control strategies as needed
• Provide support during software testing phases, including user acceptance testing (UAT), to validate that the study design builds function as intended.
• Ensure the timely and accurate reporting of quality control metrics and performance to executive leadership and key stakeholders
• Collaborate with members of the Study Design Team to implement yearly Department Roadmap projects

Education

• BS in Sciences or Medical field; advanced degree preferred

Experience/Training:

• At least 3-5 years of experience in quality control leadership roles, with a track record of developing and implementing quality control programs in the healthcare or life sciences industry
• Research experience of at least 3 years (specifically with protocols and other source documentation)

Qualifications:

• Strong analytical and problem-solving skills, with the ability to prioritize and make data-driven decisions
• Excellent communication and interpersonal skills, with the ability to build strong relationships with key stakeholders
• In-depth knowledge of regulatory requirements and industry standards, including FDA regulations, GxP guidelines, and ISO standards
• Familiarity with quality control tools and methodologies, including root cause analysis, corrective and preventive actions, and statistical process control
• Strong leadership skills, with experience managing and mentoring quality control teams

If you are a strategic thinker with a passion for ensuring quality and compliance in the healthcare or life sciences industry, and you thrive in a fast-paced, entrepreneurial environment, we want to hear from you. Please submit your resume and cover letter to be considered for this exciting opportunity.

Benefits

• Work from anywhere
• Coworking Reimbursement
• Lunch on us - During Training Days
• Unlimited PTO
• 401k company match
• Healthcare
• Dental
• Vision
• Life insurance
• Professional development

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