Job Summary

We are currently seeking an R&D Operations - Clinical Quality Management Intern for Summer 2027. This position works for approximately 37.5 hours per week.

The Summer Intern will support the day-to-day execution of Clinical Quality Oversight (CQO) activities within R&D Operations. Working under the direction and oversight of CQO team members, the intern will assist with inspection readiness activities, quality assessments, study- and function-level engagement support, quality information tracking, communications, and continuous improvement projects.

Responsibilities

The role is designed to provide practical experience in how a clinical quality team supports consistent process execution, cross-functional collaboration, and inspection-ready clinical trial delivery.

● Clinical Quality Oversight Activity Support: Execute assigned components of routine CQO activities under team oversight. This may include gathering and organizing information, reviewing materials against defined checklists or criteria, documenting observations, preparing working files, and tracking follow-up actions for team review.
● Inspection Readiness and Assessment Support: Assist with the preparation and execution of inspection readiness assessments, study-level touchpoints, functional-level touchpoints, and targeted reviews. Support meeting preparation, evidence collection, note taking, action tracking, and development of draft summaries using established tools and templates.
● Quality Information and Tracking: Maintain trackers, logs, dashboards, and supporting documentation used to monitor CQO activities, identified risks, observations, commitments, and due dates. Perform basic data checks and organize information so that CQO team members can review status, trends, and potential follow-up needs.
● Cross-Functional Meeting and Project Support: Participate in CQO and cross-functional meetings, prepare agendas or background materials, capture decisions and action items, and follow up on assigned tasks. Collaborate with colleagues across R&D functions while escalating questions or uncertainties to the supervising CQO team member.
● Tools, Communications, and Continuous Improvement: Support the development and maintenance of CQO tools, templates, job aids, presentations, and communications. Assist with process mapping, research, document comparison, and other improvement activities intended to increase clarity, consistency, efficiency, and awareness.
Internship Deliverable: Complete an assigned project or defined set of deliverables aligned with current CQO priorities. Summarize the work performed, key learnings, and recommendations or next steps in a final presentation or written report, with guidance from the CQO team.

Qualifications

● Currently enrolled in an accredited college or university, pursuing a bachelor's degree in life sciences, healthcare, pharmacy, nursing, clinical research, quality management, business, data analytics, or a related field.
● Demonstrated interest in clinical research, quality, business processes, continuous improvement, or the pharmaceutical/biotechnology industry.
● Prior pharmaceutical, biotechnology, or clinical research experience is not required.
● Enthusiasm, curiosity, eagerness to learn, and willingness to take responsibility for assigned work.
● Strong attention to detail, organization, and commitment to producing accurate, high-quality work.
● Clear written and verbal communication skills and the ability to work collaboratively in a professional, cross-functional environment.
● Ability to complete assigned tasks, manage deadlines, follow established instructions and templates, ask questions, and incorporate feedback while working with oversight.
● Analytical, problem-solving, and critical-thinking skills, including the ability to organize information and identify inconsistencies for team review.
● Basic proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
● AI and ML experience preferred.