Clinical and Medical Research Specialist

About Sequel

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.

Job Overview

The Clinical & Medical Research Specialist manages research operations activities across Sequel Med Tech’s evidence-generation portfolio, including clinical trials, post-market and observational studies, epidemiologic and real-world evidence research, secondary data analyses, and external research collaborations. This role applies research operations, project management, and data fluency to independently manage assigned projects, help prioritize deliverables, assess operational and data-related risks, and recommend actions that support compliant, timely, and audit-ready research execution.

The role works closely with internal teams, investigators, research sites, CROs, vendors, and external research organizations to align deliverables, monitor project status, evaluate dependencies, and resolve or escalate issues within defined scope. The Clinical & Medical Research Specialist also contributes to research infrastructure by managing research-related SOPs, standardized workflows, documentation practices, and data readiness activities.

This position requires strong organizational, analytical, and communication skills, along with judgment to identify issues that may affect study conduct, data integrity, participant safety, compliance, timelines, or the quality of resulting evidence.

Job Responsibilities and Essential Duties

• Manage operational activities across Sequel's portfolio of research and evidence-generation projects, including clinical trials, post-market and observational studies, epidemiologic and real-world evidence research, secondary data analyses, and external research collaborations.
• Develop, maintain, and interpret project plans, study and enrollment trackers, timelines, status reports, decision logs, and source-of-truth materials; assess project status, evaluate delays and dependencies, and recommend actions to mitigate research execution risks.
• Lead assigned research start-up and execution activities by aligning deliverables across internal stakeholders, investigators, research sites, vendors, and external partners; evaluate readiness, resolve routine barriers within scope, and escalate material risks with recommended solutions.
• Manage CRO relationships and the day-to-day operational execution of assigned CRO-led studies, including project timelines, deliverables, documentation, data needs, vendor performance, issue resolution, and cross-functional follow-up to keep research activities on track.
• Coordinate investigator-initiated and other external research collaborations with investigators, institutions, and diabetes research organizations, and work with Sequel's external product development and manufacturing partners, including DEKA and Millyard, on research-related needs.
• Ensure the collection, cleaning, organization, reconciliation, and documentation of research data; identify missing, inconsistent, or discrepant information and coordinate resolution with appropriate owners.
• Maintain well-organized, analysis-ready datasets, data dictionaries, supporting documentation, tables, graphs, dashboards, and basic descriptive summaries for analysts, biostatisticians, and approved research partners.
• Assess research and data requests from internal and external stakeholders, clarifying the research question, evaluating feasibility, identifying approval requirements, prioritizing work within defined business needs, and recommending timelines and deliverables.
• Manage research-related SOPs, work instructions, templates, and supporting documentation, including review, revision, approval, version control, implementation, and periodic updates.
• Manage research administration, including project meetings and action items, vendor and investigator coordination, study and research budget tracking, forecasts, invoices, agreements, and other project documentation; identify and communicate budget variances to Medical Affairs leadership.
• Maintain accurate, organized, and audit-ready research records for assigned projects; evaluate issues that could affect research conduct, participant safety, data integrity, compliance, timelines, or evidence quality, and determine appropriate escalation or recommended corrective action.

Minimum Requirements (Education and Experience)

• Education: Bachelor’s degree in health science, life science, public health, epidemiology, clinical research, data science or related discipline.
• Experience: 3+ years of experience supporting clinical, medical, epidemiologic, or related research programs, including experience within a medical device, pharmaceutical, biotech, or CRO environment. Experience supporting medical device research and working within a regulated industry environment is required; diabetes, digital health, or device-generated data experience is preferred.

Preferred Qualifications

• Experience with medical device, diabetes, digital health, or device generated data research
• Familiarity with Good Clinical Practice and experience working on clinical trials, post-market studies, observational or epidemiologic studies, real-world evidence or secondary data analysis.
• Experience working with research data, SOP’s, external research organizations, CRO’s investigators, sites, vendors, or other scientific collaborators.

Required Knowledge, Skills and Abilities

• Strong organizational and project-management skills, with the ability to manage and coordinate multiple research activities, priorities, timelines, and stakeholders simultaneously.
• Proficiency with Microsoft Excel and research and/or project-management systems, with the ability to maintain trackers, organize research data, monitor project status, and support accurate reporting.
• Strong attention to detail and analytical skills, including the ability to identify data discrepancies, maintain accurate study documentation, and support data cleaning and quality activities.
• Working knowledge of clinical and research operations, including IRB/ethics submissions, informed consent, study documentation, post-market research, and applicable FDA, Good Clinical Practice, and other research requirements and processes; ability to independently identify and use appropriate regulatory and industry resources and seek functional guidance when needed.
• Strong written and verbal communication skills, with the ability to work effectively with investigators, research sites, vendors, external research organizations, and cross-functional internal partners.
• Ability to develop and maintain organized, audit-ready research documentation, procedures, and standardized workflows while appropriately handling confidential information, including protected health information (PHI) and sensitive research data.
• Sound judgment regarding confidentiality, research documentation, data handling, issue escalation, and the limits of role authority.
• Ability to work independently yet use good judgment in seeking advice when necessary.
• Commitment to accurate, compliant, organized, and audit-ready research practices.
• Ability and willingness to work regularly from the Manchester, NH office and travel as required to support research activities.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Sequel, we believe that when you thrive, we thrive. That’s why our benefits package is designed to support you from day one. You’ll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We’re committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You’ll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind.

We know the importance of taking time to rest and recharge. That’s why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you’re not just starting a job, you’re building a rewarding career and a brighter future. Join us, and let’s thrive together!

Environmental/Safety/Physical Work Conditions

Ensures environmental consciousness and safe practices are exhibited in decisions

Use of computer and telephone equipment and other related office accessories/devices to complete assignments

May work extended hours during peak business cycles

Physical requirements such as lifting specific weights

Some travelling is expected