Site Identification Analyst II

11 Premier Research International LLC; Plymouth (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Premier Research is seeking a Site Identification Analyst II to support our Clinical Monitoring, Site Management and SSU team in Plymouth, NC. You will build relationships to gather business intelligence, oversee post-award Site ID activities, and manage CTMS workflows to meet study timelines.

The role requires a science-oriented undergraduate degree, CTMS/EDC experience, and strong analytical skills to support site identification and trial startup efforts at a leading biotech-focused CRO.

Qualifications

• Undergraduate degree or its international equivalent preferably in the Sciences or in a related field from an accredited institution.
• Three years of data management, clinical operations, or start-up experience in the Pharmaceutical, Biotech, and Medical Device industry
• Two years' experience in supporting CTMS
• Experience in clinical trials support, site partnership management, site identification/selection or pharmaceutical industry highly prioritized
• Strong analytical and problem-solving skills
• Good working knowledge of Clinical database applications such as EDC and CTMS

Responsibilities

• Proactively builds and maintains internal and external relationships to support the gathering of business intelligence to support financial & specific operational activities
• Oversees site outreach for post award Site ID activities
• Progresses and tracks in the CTMS site identification activities according to study timelines; manages time and project requirements based on study contract and works with internal and external customers/vendors to meet project specific goals.
• Provides weekly project progress reports to Internal and External project teams including department management; may provide information from the Investigator Database regarding timelines, site contact information, PI specialty, etc.
• Updates Investigator Database with new sites and investigators, reviewing entries for duplicates, and any information obtained during the site selection process as well as after studies have completed.
• Oversees the distribution, tracking and review of SRQs for completeness, site capability and availability based on project specific requirements and needs; identifies, monitors, documents, and tracks out-of-scope activities.
• Assists in the design and implementation of all relevant systems including, but not limited to, the site identification metrics and reporting, surveys, etc.

Skills

Analytical skills

Problem-solving

Education

Bachelor's degree in science or related field

Tools

EDC

CTMS

Job description

Premier Research is looking for a Site Identification Analyst II to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Proactively builds and maintains internal and external relationships to support the gathering of business intelligence to support financial & specific operational activities
• Oversees site outreach for post award Site ID activities
• Progresses and tracks in the CTMS site identification activities according to study timelines; manages time and project requirements based on study contract and works with internal and external customers/vendors to meet project specific goals.
• Provides weekly project progress reports to Internal and External project teams including department management; may provide information from the Investigator Database regarding timelines, site contact information, PI specialty, etc.
• Updates Investigator Database with new sites and investigators, reviewing entries for duplicates, and any information obtained during the site selection process as well as after studies have completed.
• Oversees the distribution, tracking and review of SRQs for completeness, site capability and availability based on project specific requirements and needs; identifies, monitors, documents, and tracks out-of-scope activities.
• Assists in the design and implementation of all relevant systems including, but not limited to, the site identification metrics and reporting, surveys, etc.
• Please note the official title for this position is: Clinical Business Operations Analyst II - Systems and Data

What We Are Searching For:

• Undergraduate degree or its international equivalent preferably in the Sciences or in a related field from an accredited institution
• Three years of data management, clinical operations, or start-up experience in the Pharmaceutical, Biotech, and Medical Device industry
• Two years' experience in supporting CTMS
• Experience in clinical trials support, site partnership management, site identification/selection or pharmaceutical industry highly prioritized
• Strong analytical and problem-solving skills
• Good working knowledge of Clinical database applications such as EDC and CTMS

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.