Manager, Clinical Systems (IRT) - Remote Opportunity with Workwarp in San Diego

Join Our Team: Revolutionizing Clinical Trials with Interactive Response Technologies

At Workwarp, we're at the forefront of transforming the clinical trial landscape through innovative Interactive Response Technologies (IRT). As a leader in this field, we're seeking a highly skilled and experienced Manager, Clinical Systems (IRT) to join our team on a remote basis in San Diego. If you're passionate about leveraging technology to streamline clinical trials and have a proven track record in IRT, we want to hear from you.

About Our Company and Industry

Workwarp operates in the dynamic and rapidly evolving pharmaceutical and biotech industry, where the adoption of cutting-edge technologies is crucial for accelerating the development of new treatments and therapies. Our company is dedicated to providing top-notch IRT solutions that enable our clients to manage clinical trials more efficiently, ensuring compliance with regulatory requirements and industry best practices. As a Manager, Clinical Systems (IRT), you will play a pivotal role in our mission to deliver exceptional service and support to our clients.

Key Responsibilities

• Championing Efficient IRT Design: Serve as the expert and consultant for designing and implementing IRT systems that meet the specific needs of each clinical trial, ensuring adherence to study protocols and regulatory requirements.
• Leading System Requirements Gathering: Facilitate meetings with clinical study teams and IRT suppliers to gather and document system requirements, ensuring that all stakeholders are aligned and informed.
• Overseeing Technical Documentation: Design and oversee the development of study-specific technical documents, maintaining high standards of quality and compliance.
• Risk Management and Issue Resolution: Identify, document, and mitigate risks and issues in partnership with study teams and technology suppliers, ensuring timely resolution and minimal impact on project timelines.
• Project Management: Closely manage project-related timelines and activities, ensuring that all deliverables are met on time and to the required standard.

Qualifications and Skills

Basic Qualifications

To be considered for this role, you must have:

• A Doctorate Degree; or
• A Master's Degree with 3 years of IRT experience; or
• A Bachelor's Degree with 5 years of IRT experience; or
• An Associate's degree with 10 years of IRT experience; or
• A High school diploma/GED with 12 years of IRT experience.

Preferred Qualifications

While the above qualifications are essential, the following preferred qualifications will make you a more competitive candidate:

• 5+ years of experience in IRT, preferably in a clinical trial setting.
• A Bachelor's Degree in life sciences, computer science, engineering, business, or a related discipline.
• 4+ years of experience in clinical operations, clinical supply chain, or clinical systems management.
• Experience with implementing clinical systems such as IRT and eCOA.
• Working knowledge of Good Clinical Practices (GCP) and FDA regulations governing clinical trials.
• Excellent documentation, communication, and meeting management skills.
• Proven vendor management experience.
• Strong time management and organizational skills, with the ability to work in a timeline-driven environment.
• Sound judgment and decision-making abilities, with a track record of resolving complex problems.
• The ability to work effectively in a team-based environment with minimal supervision.

What We Offer

As a Manager, Clinical Systems (IRT) at Workwarp, you can expect:

• A competitive salary that reflects your experience and qualifications.
• A long-term contract with the possibility of extension beyond the initial term.
• Opportunities for career growth and professional development in a dynamic and innovative industry.
• The flexibility of working remotely from San Diego, with the opportunity to collaborate with a talented team of professionals.
• A culture that values innovation, teamwork, and excellence.

Why This Role Matters

This position is a backfill for an external worker who has moved into a new role, and we're looking for someone who can hit the ground running. As a Manager, Clinical Systems (IRT), you will be responsible for managing projects, negotiating with external vendors, and working in a regulated environment. Your skills and experience will be crucial in driving our mission forward and delivering exceptional results for our clients.

Top 3 Must-Have Skill Sets

• Negotiation with external vendors.
• Management of projects and people.
• Familiarity with documentation in a regulated environment.

Join Our Team

If you're a motivated and experienced professional looking for a challenging and rewarding role, we want to hear from you. Apply today to join our team and be part of shaping the future of clinical trials through innovative IRT solutions.

Don't miss this opportunity to take your career to the next level. Apply now and let's build the future together.