Clinical and Medical Research Specialist

Sequel Med Tech•Marlborough, MA

22d•$100,000 - $110,000•Onsite

About The Position

The Clinical & Medical Research Specialist manages research operations 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. The role independently manages assigned projects, helps prioritize deliverables, assesses operational and data-related risks, and recommends actions to support compliant, timely, and audit-ready research execution. The specialist works 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 the role’s defined scope. The position also contributes to research infrastructure through management of research-related SOPs, standardized workflows, documentation practices, and data-readiness activities. The role requires strong organizational, analytical, and communication skills, along with judgment to identify issues that could affect study conduct, participant safety, data integrity, compliance, timelines, or evidence quality. Regular work from the Manchester, New Hampshire office and travel as required are expected.

Requirements

Bachelor’s degree in health science, life science, public health, epidemiology, clinical research, data science, or a related discipline.
At least 3 years of experience supporting clinical, medical, epidemiologic, or related research programs, including experience in a medical device, pharmaceutical, biotech, or CRO environment.
Experience supporting medical device research and working in a regulated industry environment.
Strong organizational and project-management skills, including the ability to coordinate multiple research activities, priorities, timelines, and stakeholders.
Proficiency with Microsoft Excel and research and/or project-management systems, including maintaining trackers, organizing research data, monitoring project status, and supporting reporting.
Strong attention to detail and analytical skills, including identifying data discrepancies, maintaining study documentation, and supporting 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 identify and use appropriate regulatory and industry resources independently and seek functional guidance when needed.
Strong written and verbal communication skills for working with investigators, research sites, vendors, external research organizations, and internal cross-functional partners.
Ability to develop and maintain organized, audit-ready research documentation, procedures, and standardized workflows while appropriately handling confidential information, including 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 and 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, New Hampshire office and travel as required to support research activities.

Nice To Haves

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, SOPs, external research organizations, CROs, investigators, research sites, vendors, or other scientific collaborators.

Responsibilities

Manage operational activities across 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 status, delays, and dependencies, and recommend actions to mitigate execution risks.
Lead assigned research start-up and execution activities by aligning deliverables across internal stakeholders, investigators, research sites, vendors, and external partners; assess readiness, address routine barriers within scope, and escalate material risks with recommended solutions.
Manage CRO relationships and day-to-day operations of assigned CRO-led studies, including timelines, deliverables, documentation, data needs, vendor performance, issue resolution, and cross-functional follow-up.
Coordinate investigator-initiated and other external research collaborations with investigators, institutions, and diabetes research organizations, and work with external product development and manufacturing partners, including DEKA and Millyard, on research-related needs.
Ensure research data are collected, cleaned, organized, reconciled, and documented; identify missing, inconsistent, or discrepant information and coordinate resolution.
Maintain organized, analysis-ready datasets, data dictionaries, supporting documentation, tables, graphs, dashboards, and basic descriptive summaries for analysts, biostatisticians, and approved research partners.
Assess internal and external research and data requests by clarifying research questions, evaluating feasibility, identifying approval requirements, prioritizing work, 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 meetings and action items, vendor and investigator coordination, study and research budget tracking, forecasts, invoices, agreements, and project documentation; identify and communicate budget variances to Medical Affairs leadership.
Maintain accurate, organized, audit-ready research records; assess issues affecting research conduct, participant safety, data integrity, compliance, timelines, or evidence quality, and determine appropriate escalation or recommended corrective action.

Benefits

401(k) plan with a 6% company match and 100% immediate vesting.
Capped out-of-pocket insulin costs and GLP-1 coverage across all health plans.
Meritain health insurance plans.
Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs).
Vision and dental coverage.
Voluntary long-term disability, accident, critical illness, and hospital indemnity coverage.
Discounts for pet care.
Employer-paid short-term disability and life insurance.
Flexible PTO.
Paid holidays.
Flex Time options.