Clinical Research Scientist Job Description

As the Clinical Research Scientist, you own the clinical evidence strategy for a medical device portfolio, ensuring studies run with partner sites are scientifically rigorous and yield clinically meaningful results. You will work alongside the medical director, biostatisticians, and engineering leads within a matrixed clinical team, with frequent exposure to executive leadership.

Career Impact: Each accepted first-author manuscript in a peer-reviewed journal adds to a citable publication record, which device employers list as a hiring requirement.

Business Impact: Well-designed pivotal and post-market follow-up studies give sales and market access teams the evidence needed to win reimbursement.

Growth Opportunity: As device teams expand, the role grows from running studies to managing incoming scientists on research and data analysis projects.

Company Value: Device teams in this space emphasize patient-centered innovation and direct mentorship from global clinical experts in surgery and neuromodulation.

• Design clinical studies and experiments for devices under development, defining the evidence needed to meet product development goals.
• Develop clinical study protocols, informed consent forms, and case report forms for IRB and ethics committee submission.
• Review published literature and competitive clinical evidence to justify trial design and inform device evaluations.
• Monitor clinical and human study datasets for completeness, interpreting results against the statistical analysis plan.
• Own clinical study reports, Clinical Evaluation Reports, and clinical sections of submissions to agencies and notified bodies.
• Lead publication of study outcomes, coordinating abstracts, posters, and manuscripts for peer-reviewed medical journals.
• Partner with engineering and product teams to define device performance testing and collect data for validation.
• Coordinate external research sites, investigators, and contract research organisations to keep studies on schedule.

• Master's degree in life sciences, biomedical engineering, or a quantitative scientific field, or equivalent work experience.
• 3 or more years of clinical research experience, including studies with human subjects in a regulated environment.
• Working knowledge of Good Clinical Practice, ICH guidelines, and clinical trial regulations governing medical devices.
• Demonstrated ability to develop hypotheses, design studies, and write protocols that isolate multiple potential effects.
• Strong data analysis and interpretation skills applied to clinical, physiologic, or human study datasets and statistical plans.
• Proven medical or technical writing ability, including manuscripts accepted by peer-reviewed journals.
• Clear oral and written communication of complex findings to technical and non-technical audiences.
• Ability to work independently with minimal direction while delivering results within cross-functional, multidisciplinary project teams.

• Doctoral degree in systems neuroscience, bioengineering, computational biology, or a related quantitative discipline.
• Track record supporting device regulatory submissions and responding to questions from agencies or notified bodies.
• Background in signal processing, machine learning, or scripting for batch pre-processing and statistical analysis of data.
• Domain experience in neuromodulation, neuroscience, or electrophysiology research, including analysis of recorded data in human or animal models.

• Protocol approval cycle time in days, showing how submission-ready drafted protocols are.
• On-time study milestone rate (%), reflecting coordination of sites, investigators, and CROs.
• Regulatory questions received per submission (count), indicating clarity of authored clinical sections.
• Peer-reviewed publications and abstracts accepted per year, tracking dissemination of study outcomes.
• CER completion time in days, measuring literature review and evaluation report efficiency.
• Complete, query-free dataset rate (%), reflecting oversight of incoming study data.

• Base Salary Range: $120,000 to $165,000 annually, depending on degree and experience
• Bonus: Annual performance bonus, typically 10% to 15% of base salary
• Equity: Stock options or RSUs, common at venture-backed and public device companies
• Health Benefits: Medical, dental, and vision coverage with HSA or FSA options
• PTO: 15 to 25 days annually plus company holidays
• Common Perks: 401(k) match, conference travel, publication support, and professional development funding

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Offers are contingent on successfully completing a background check, which may include verification of credentials, education, and clinical research roles. Candidates must be authorized to work in the United States. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by federal, state, or local law. Reasonable accommodations during the application process or on the job are available upon request.

The Clinical Research Scientist leads the design of preclinical and clinical neuromodulation studies, writing protocols and statistical analysis plans and turning high-dimensional physiologic data into publications that support clinical and commercial objectives. Reporting to research leadership within a growing neuroscience team, the scientist works alongside engineers and external research sites.

Key Responsibilities

• Design preclinical and clinical research studies using insights from literature reviews, data analytics, neuroscience knowledge, and stakeholder input.
• Write clinical study protocols and statistical analysis plans.
• Provide oversight on external study collaborations, including drafting project documentation, tracking study timelines, and maintaining communication with research sites.
• Utilize advanced statistical, mathematical, and predictive modeling to build algorithms.
• Develop reports, abstracts, and manuscripts for publication of research study outcomes.
• Assist in the development and preparation of external data presentations.
• Develop, demonstrate, and communicate the company's understanding of neural mechanisms to the field.
• Support management of data derived from clinical and real-world use of the company's therapies.
• Develop and manage interactive data visualization and analytic tools for reporting.
• Identify new technologies, concepts, and methodologies that will help address complex, non-routine, and evolving needs of various departments.
• Identify issues from data collection through analysis, develop relevant testing protocols, and support engineers in implementing solutions.
• Support building, running, and analyzing finite element analysis and computational neuroscience modeling simulations.
• Manage incoming scientists for research and data analysis projects as the team grows.

Required Qualifications

• Graduate degree in a quantitative scientific field (statistics, mathematics, computer science, computational biology, or engineering).
• 5+ years of experience in basic scientific or clinical research in neuroscience, neuromodulation, or related areas.
• Experience leading preclinical or clinical study design and writing study protocols.
• Strong publication record in peer-reviewed journals.
• Strong background in physiologic data analysis, preferably with experience analyzing clinical and electrophysiology-recorded data in human or animal models.
• Full-stack experience in data collection, aggregation, analysis, visualization, and monitoring of data science products.
• Robust skills in statistics, probability, and/or machine learning.
• 3+ years of experience with scripting languages for pre-processing and statistical analysis (e.g., Python, R, MatLab).
• Experience in finite element modeling (e.g., Comsol, Ansys, Sim4Life) and/or computational neuroscience modeling (e.g., Neuron simulation environment) is a plus.
• Excellent team player and communicator with a demonstrated track record of success in a cross-functional team environment.
• Passion for patient-centered innovation to improve both health and healthcare.

Embedded within a growing surgical device team, the Clinical Research Scientist delivers pre-clinical and clinical studies that meet global regulatory standards, from protocols and informed consents to Clinical Evaluation Reports. Working closely with Engineering, Quality & Regulatory Affairs, Contract Research Organisations, and study investigators, the scientist generates evidence that supports regulatory submissions, market access, and reimbursement.

Core Functions

• Contribute to the development and delivery of evidence generation and dissemination plans for pre-clinical and clinical studies to support the development pipeline, in collaboration with cross-functional partners (Engineering, Sales & Marketing, Quality & Regulatory Affairs).
• Set up and execute clinical trial protocols, informed consents, investigator brochures, and other study materials.
• Identify and manage working relationships with Contract Research Organisations where indicated to ensure timely delivery of clinical trials.
• Contribute to the delivery of pre-clinical and clinical studies on time and in compliance with regulations and SOPs.
• Develop strong collaborative relationships with study teams, including investigators, research nurses, CROs, and consultants.
• Draft study reports for assigned studies, including annual reports for IRBs/ECs as needed, study close-out reports, and clinical sections for regulatory submissions.
• Critically assess the literature and draft Clinical Evaluation Reports (CERs).
• Support clinical scientific discussions with regulatory agencies and notified bodies to drive support of the clinical and regulatory strategy.
• Contribute to the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, study reports, and use of data for market access and reimbursement.
• Ensure registration on www.clinicaltrials.gov from study initiation through posting of results.

Qualifications & Experience

• Degree in medicine, nursing, healthcare, biomedical and life sciences, or another relevant discipline.
• Previous experience in a scientific, technical, or clinical research role with a strong record of successful clinical trial delivery, ideally in medical devices.
• Experience in design, documentation, data management, and interpretation of clinical trial results.
• Deep and practical understanding of ICH-GCP, clinical trial regulations, and local legislation.
• Understanding of research science and processes, product development processes, team dynamics, the related healthcare market environment, clinical trends, and global clinical trial regulations.
• Ability to provide scientific research input across development and life-cycle studies.
• Genuine desire to help and support team members so that everyone can achieve their best.
• Willingness to take ownership, make decisions, and deliver solutions.

Reporting to surgery project leadership, the Clinical Research Scientist shapes clinical evidence strategies for surgical products and therapies, designing ex vivo, in vitro, and in vivo studies that answer key clinical questions. Partnering with key opinion leaders and a multi-disciplinary project team, the scientist helps improve the standard of care and surgical outcomes through regulatory support and clinical education.

Primary Duties

• Help a multi-disciplinary project team solve challenges and uncertainties by applying physiological knowledge and clinical research.
• Work with the project team to answer key clinical questions by performing literature searches and sharing information with the team.
• Design and manage clinical studies and trials at various project stages (ex vivo, in vitro, in vivo) to build understanding or evidence supporting project objectives.
• Help identify the right clinical evidence for a product or therapy and how best to build evidence to support it.
• Identify and build relationships with key opinion leaders to leverage their expertise for the project and their influence to drive clinical change.
• Support regulatory reviews and submissions.
• Create and conduct clinical training and education for a variety of audiences.

Skills & Qualifications

• Demonstrated experience in medical or technical writing.
• Experience with clinical research, including protocol design, ethics submission, agreements, budgets, and statistical analysis.
• In-depth knowledge of Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) and a strong understanding of research methodology.
• Ability to search and summarise clinical literature.
• Exceptional oral presentation skills for a variety of stakeholders.
• Great communication skills and a strong ability to build relationships within a multi-disciplinary team and with healthcare professionals.

Sitting at the intersection of clinical research and medical device engineering, the Clinical Research Scientist owns the evidence generation strategy for a device portfolio, defining the studies and validation plans needed to reach product development goals. Operating across Product Management, engineering, and Data Science & Biostatistics, the scientist authors study reports and peer-reviewed manuscripts that strengthen regulatory filings and scientific credibility.

Duties

• Drive the evidence generation strategy for devices in the portfolio with both internal and external partners.
• Define the type of evidence needed to achieve product development goals, design a series of clinical studies and experiments, and work with the team to draft clinical study protocols and other study materials for IRB submission.
• Work closely with Product Managers and engineers to define the approach to testing device performance against requirements.
• Collaborate closely with Data Science & Biostatistics to perform literature reviews and develop analytical and clinical validation plans for devices under consideration.
• Author clinical study reports and other clinical documents.
• Prepare abstracts, poster presentations, slides, and manuscripts for publication in peer-reviewed medical and technical journals.

Requirements

• Advanced degree (PhD) and background in a quantitative field of biology (systems neuroscience, bioengineering, computational biology, etc.).
• Minimum 5 years of experience in developing medical devices or digital health tools and conducting clinical research with human subjects, or equivalent.
• Experience working in a regulated space (medical device, drug) and supporting regulatory submissions.
• Ability to develop hypotheses, design experiments, and develop analytical plans.
• Preferred background in signal processing, data science, or machine learning.
• Demonstrated writing ability for medical and/or technical journals.
• Ability to synthesize outcomes of clinical research and complex machine learning techniques and communicate ideas orally or in writing to technical and non-technical audiences.
• Demonstrated ability to deliver against timelines and execute in rapidly evolving circumstances.

A key member of an early-phase clinical research team, the Clinical Research Scientist I delivers scientific and regulatory support for study designs, from literature searches to protocol reviews and updates to scientific databases. Collaborating across internal teams, clients, ethics committees, and regulatory agencies, the scientist keeps deliverables on schedule and integrates stakeholder feedback into protocols.

Functions

• Provide scientific and regulatory support for study designs, such as literature searches.
• Support team members with designs, synopses, protocols, related documents, and related quality control activities.
• Participate in reviewing Early Phase protocols prepared by clients.
• Participate in reviewing project documents prepared by other internal teams, such as SAPs and Clinical Study Reports.
• Actively participate in regulatory monitoring and intelligence, and prepare, revise, and update scientific databases (e.g., Scientia) used by other internal teams.
• Track assigned documents and deliverables until the end of the study, deliver within required timelines, and address and manage related issues.
• Independently prepare and present scientific material at internal calls.
• Synthesize and integrate comments from clients, internal stakeholders, the ethics committee, and regulatory agencies into documents such as protocols, both pre and post-study.

Experience & Qualifications

• Master's Degree (or equivalent) level of qualification in life sciences.
• Clinical research organization (CRO) experience preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, the drug development process, and literature research.
• Good computer skills, especially in Microsoft Word, Excel, PowerPoint, and Acrobat, with the ability to embrace new technologies.
• Strong ability to manage time and work independently.
• Excellent written and spoken communication, presentation, and interpersonal skills, with the ability to inform, influence, convince, and persuade.
• Fluency in English is required.

Reliable data for clinical, user, and prototype evaluation studies depends on the Clinical Research Scientist, who builds study protocols, plans, and budgets and designs proof-of-concept studies for benchtop analytical instrumentation. Serving as a conduit between development, experimental, and analytical teams, the scientist monitors dataset quality and keeps study execution aligned with objectives.

Accountabilities

• Assist internal and external groups in developing study protocols, plans, budgets, and schedules and managing logistics for the execution of clinical and user studies.
• Act as part of the conduit between development, experimental, and analytical teams to ensure study design and execution are consistent with study objectives.
• Collaborate with team members to communicate study progress, results, schedule, and budget to the project team.
• Design and execute prove-in studies for bench-top analytical instrumentation to provide reliable and meaningful data for prototype evaluation.
• Monitor the quality and completeness of datasets returned from user studies in progress.
• Participate in analysis and interpretation of human study datasets.

Technical Qualifications

• 2+ years of technical experience.
• Experience designing, executing, and monitoring human studies is preferred.
• Good laboratory practices, including experience with wet lab methods.
• Strong analytical and computational skills.
• Detail-oriented and highly organized.
• Excellent communication and interpersonal skills.

As the Clinical Research Scientist, this role leads clinical research work across drug and medical device projects, managing external service providers and preparing study documents such as protocols, investigator brochures, and case report forms. The R&D project team relies on this work to monitor clinical progress and maintain compliance with GCP, ISO 14155, and other regulatory requirements.

Activities

• Cooperate with and manage external service providers in the field of clinical research.
• Prepare and review study-specific documents such as IBs, protocols, CRFs, and CSRs.
• Provide scientific support for R&D projects within the project team.
• Monitor clinical project progress.
• Ensure compliance with relevant regulatory requirements for drugs and medical devices.

Position Requirements

• Degree in natural sciences.
• Experience with clinical trials and knowledge of GCP and ISO 14155.
• Experience with pharmacovigilance in clinical trials preferred.
• Basic medical and immunological knowledge ideally.
• Good computer skills.
• Ability to work independently and reliably and to accompany a multidisciplinary team on a project-related basis.
• High social and communication skills.
• Good spoken and written German and English (C1).

Clinical Research Scientist shapes innovative and feasible clinical trial designs for an assigned therapeutic area, monitoring safety and efficacy data and informing statistical analysis plans within Phase I-III biotech drug development programs. Success in the position means partnering effectively with clinical development, safety sciences, statistics, regulatory, and Data Management teams to turn clinical findings into sound decisions and clinical strategy.

Operational Focus

• Design innovative and feasible clinical trials in collaboration with clinical development team members.
• Regularly monitor, clean, analyze, and review safety and efficacy data to identify and summarize findings and drive follow-up activities as appropriate.
• Interface with discovery, safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, and other members of the extended project teams.
• Maintain and analyze literature and competitive information on trial designs and results for the assigned therapeutic area.
• Review and provide input on the statistical analysis plan.
• Participate, under medical supervision, in tracking and analyzing potential safety events within individual clinical trials and across trials for assigned programs.
• Partner with Data Management on case report form (CRF) design, instructions for unique CRFs, and the Data Quality Plan.
• Maintain current knowledge of scientific, clinical, competitive, and regulatory developments that could impact the development plan by attending major scientific conferences, participating in competitive intelligence activities, and engaging in periodic literature review.

Knowledge Skills & Abilities

• RN, MS, PhD, PharmD, or equivalent, with advanced degree candidates preferred.
• 3+ years of industry clinical development experience, including clinical trial experience.
• Extensive knowledge of clinical research and experience across Phase I-III drug development projects.
• Familiarity with clinical trial design and experience authoring Phase I or II clinical trial protocols.
• Experience in analyzing, interpreting, and presenting clinical data to inform decision making and clinical strategy.
• Experience in a busy, highly collaborative biotech environment as part of a cross-functional team is highly desired.
• Well-versed in medical aspects of GCP, ICH, FDA, EMEA, and other relevant guidelines.
• Ability to convey written and verbal information effectively and efficiently.
• Strong oral and written communication skills, including presenting complex findings to senior management and external audiences and preparing documents for regulatory submissions.
• Ability to work well independently and organize priorities and deliverables.
• Receptiveness to constructive feedback and understanding of the need for growth.

The Clinical Research Scientist oversees clinical biomarker plans for late-pre-clinical and early clinical programs, managing assay transfer, fit-for-purpose validation, and CRO sample testing that generate data for INDs, CTAs, and BLAs. Reporting to clinical development leadership, the scientist collaborates with translational, biostatistics, and clinical operations teams within a cross-functional matrixed setting.

Key Deliverables

• Collaborate cross-functionally with nonclinical, translational, and clinical functions to support clinical biomarker plans, then lead their implementation for late-pre-clinical and future clinical programs.
• Identify robust assay platforms and vendors suitable for clinical sample analysis.
• Support development and lead assay transfer of clinical biomarkers to appropriate vendors, and oversee vendor assay development work, fit-for-purpose validation, and report generation.
• Oversee external CRO activities, including assay development, validation, and sample testing, to generate biomarker data supporting INDs/CTAs and BLAs.
• Ensure, in collaboration with clinical operations, that clinical sample collection and analysis proceed smoothly, confirm data quality, and oversee sample analysis reports within agreed timelines.
• Collaborate with subject matter experts, biostatistics, programming, and data management to ensure appropriate analysis, reporting, and interpretation of raw biomarker data, PD, and PK/PD analyses.
• Collaborate with discovery, research, and translational functions on proactive biomarker planning and generation of IND-enabling non-clinical data for early-stage compounds.
• Participate in planning and authoring regulatory and clinical documents, posters, and publications.
• Serve as a resource for developing biomarker plans and assays for late-stage discovery and early development candidate-stage programs.

Professional Experience

• Advanced degree (Ph.D. or equivalent) in the biological or medical sciences, with M.S. and B.S. degrees considered based on relevant industry experience.
• Minimum 5+ years of industry or clinical laboratory experience in biomarker assays, including method development, transfer, qualification, validation, and clinical trial implementation, molecular technologies (e.g., NGS, FACS, IHC, ELISA, other ligand-binding methods), and cell-based ex vivo assays with associated data analysis.
• Experience in novel liquid biomarker assessments and/or CDx development is a plus.
• Background in rare diseases or genetic therapies preferred.
• Knowledge of fit-for-purpose, GLP-compliant, or CLIA-compliant assay validation requirements and experience applying them based on development stage and biomarker status.
• Familiarity with submission-level reporting and data quality standards, with familiarity in genomic and pathology assays and methodologies desired.
• Assay problem-solving and analytical skills, including resolving technical issues during method development, assay validation, and sample assessment.
• Knowledge of selecting and overseeing assay vendors to support national and global clinical trials.
• Excellent collaboration skills and demonstrated success in a cross-functional matrixed setting.

Embedded within clinical development, the Clinical Research Scientist develops protocol documents with CROs and vendors and provides scientific review of protocol data, adverse events, and statistical analysis plans from study design through final reporting. Working closely with the Clinical Scientist, Medical Monitor, and cross-functional teams, the scientist upholds SOP adherence and supports regulatory responses, due diligence, and publications for the program.

Areas of Ownership

• Collaborate with internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents.
• Contribute to scientific and operational aspects of protocol development and execution, from study design planning through final reporting of results.
• Provide scientific input and review of protocol data, and support assessment of medical monitoring reports, study integrity and conduct, and protocol oversight.
• Support preparation of abstracts, manuscripts, presentations, and meeting materials related to the protocols and program.
• Provide protocol-level scientific review of information to support development.
• Support enrollment projections and assist with developing and implementing subject recruitment and retention strategies.
• Collaborate with team members on Data Management activities, including eCRF edit checks, report development, and database lock processes.
• Participate in data review, database lock, medical monitoring, and query resolution for the protocol.
• Work with the clinical scientist, medical monitors, and drug safety vendors to provide support and scientific review of adverse events.
• Provide scientific review of statistical analysis plans.
• Develop, review, and revise departmental and corporate SOPs and processes.
• Provide clinical development and technical expertise in support of due diligence activities.
• Support protocol-level regulatory activities to develop, prepare, and respond to regulatory authorities.

Education & Experience

• Pharm.D. or Ph.D. required.
• Minimum 1-3 years of drug development experience.
• Basic understanding of biostatistics and data management.
• Strong medical writing and presentation skills.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Excellent written and oral communication skills.
• Meeting management and cross-functional team leadership skills.
• Time management and organizational skills.
• Ability to succeed in a fast-paced environment and work successfully in a matrix team environment.
• Ability to work independently.
• Ability to interact successfully in a dynamic and culturally diverse workplace.

Reporting to Global Clinical Affairs leadership, the Clinical Research Scientist advances clinical research of Tumor Treating Fields in lung, pancreatic, ovarian, and hepatocellular cancer trials by training and communicating with investigators and key opinion leaders. Partnering with clinical trial teams on site identification and enrollment, the scientist helps move a novel oncology technology through pivotal trials.

Role Responsibilities

• Develop strong and productive relationships with clinical investigators.
• Appropriately disseminate clinical and scientific information related to the company's clinical program.
• Communicate externally with investigators and clinical research professionals during conferences, scientific meetings, symposia, webinars, and individual meetings.
• Support clinical affairs and clinical trial teams in identifying potential new investigators and clinical sites and developing relationships with them.
• Provide input into clinical protocol development.
• Provide input into DSMB-related data.
• Act as the first point of contact for clinical and medical clarification from investigative sites.
• Support clinical patient enrollment efforts.

Background & Experience

• Advanced scientific degree (MD preferred), with PhD or PharmD holders with extensive experience considered.
• At least 3 years of clinical research experience in a similar position.
• Previous oncology experience is an advantage.
• Extensive medical, scientific, and clinical research knowledge.
• Ideally, some knowledge and understanding of scientific data related to TTFields.
• Very good presentation skills.
• Advanced written and verbal communication and interpersonal skills.
• Ability to work independently, exercise sound judgment, and escalate issues when necessary.
• Ability to work efficiently and collaboratively under pressure.

Sitting at the intersection of business development and clinical science, the Clinical Research Scientist II develops medical and scientific input for assigned clinical development programs, contributing to protocols, study reports, and regulatory documents. Operating across multiple projects under the Executive Director, Clinical Development, the scientist cultivates investigator and clinician relationships that foster innovation, support due diligence, and advance clinical development goals.

Job Functions

• Provide medical and scientific expertise to assigned clinical development programs.
• Contribute, under the guidance of the clinical team, to protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents.
• Contribute to the design and execution of projects supporting clinical research programs.
• Participate in study management and/or clinical development teams to facilitate clinical development goals and achievement of study quality metrics.
• Contribute to organizing, preparing, and executing investigator and advisory board meetings with project teams and stakeholders.
• Remain up to date on regulations and guidelines for the therapeutic area and scientific advances in the relevant field, both internal and external to the company.
• Cultivate relationships with external partners such as clinical investigators, clinicians, and scientists to support innovation and business development.
• Assist with due diligence as it pertains to business development opportunities.

Required Qualifications

• Doctorate degree (M.D., Ph.D., or Pharm.D.) in a related area.
• 3-5 years of clinical/research experience.
• Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
• Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Experience in analysis and interpretation of clinical safety and efficacy data.
• Excellent written and verbal communication and presentation skills.
• High level of organizational and project management skills.
• Ability to make independent, timely, and appropriate decisions.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and effectively across multiple projects within a designated therapeutic area.
• Intellectual curiosity, flexibility, and persistence.

A key member of a medical device research function, the Clinical Research Scientist produces clinical study protocols, clinical evaluation reports, and peer-reviewed publications, backed by comprehensive literature searches and competitive evidence analysis. Collaborating across Engineering, Marketing, and Customer Support, the scientist ensures partner studies are scientifically rigorous and yield clinically meaningful results.

What You'll Do

• Draft clinical study protocols, clinical evaluation reports, post-market clinical follow-up plans, and other study materials.
• Prepare abstracts, posters, and presentations for conferences, and manuscripts for publication in peer-reviewed medical journals.
• Conduct comprehensive literature searches for product and technology evaluations and write ad hoc reports for internal distribution or regulatory submission.
• Analyze all kinds of clinical evidence for competitors' products (public, proprietary, published, unpublished) from all sources (journals, internal documents, regulatory submissions).
• Remain current with publications and public database registrations on similar and competitive products, keeping abreast of current literature, emerging science, and technological developments and trends.
• Support development and editing of clinical SOPs.
• Review data from clinical studies and create ad hoc reports for internal distribution.
• Work closely with engineering teams to collect data for development and validation.
• Clearly synthesize and communicate research findings and recommendations to cross-functional team members.
• Write computer programs and scripts in languages including C, Python, Matlab, and/or Linux to perform batch data processing whenever possible.

Qualifications & Experience

• Master's Degree in biomedical engineering, bioengineering, mechanical engineering, or related science.
• 1+ years of research experience.
• Demonstrated writing ability for medical journal publications.
• Robust ability to gather and interpret baseline data and design studies effective at separating out multiple potential effects.
• Ability to synthesize clinical research and communicate ideas clearly and concisely, orally or in writing, to varied audiences.
• Strong project management, organizational, and interpersonal communication skills.
• Excellent attention to detail.
• Ability to work well independently and with minimal direction at times.

Credible neuromodulation trial data and publications depend on the Clinical Research Scientist, who refines trial design justification, critically analyzes statistical analysis plans and data sets, and leads study-level publication planning. Based within a neuromodulation clinical study team alongside the medical director and biostatistician, the scientist prepares regulatory submission documents and interacts with executive leadership, physicians, and regulatory authorities.

Day-to-Day Responsibilities

• Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development.
• Generate study-related documents, including but not limited to reports of prior investigations, investigational brochures, protocols, informed consent forms, and case report forms.
• Synthesize literature and competitive information on trial designs and results for the assigned therapeutic area.
• Review and critically analyze statistical analysis plans.
• Review and critically analyze data sets.
• Lead study-level publication planning, including manuscript writing and submission.
• Lead publications of clinical study data by coordinating with investigator authors and managing reviews and revisions of abstracts and manuscripts.
• Generate documents to support regulatory submissions and/or respond to regulatory authority questions about existing submissions.

Skills & Qualifications

• Doctorate degree in a relevant science.
• At least 5 years of relevant work experience.
• Experience conducting research in human subjects.
• Experience working in a highly matrixed and geographically diverse business environment.
• Strong data analysis and interpretation skills.
• Strong verbal and written communication and interpersonal skills.
• Strong leadership skills for significant interaction with executive leadership, physicians, and regulatory authorities.