Clinical Scientist

Providence Medical Technology, Inc.; United States; Hybrid; USD 90,000 - 120,000; Full time

Job summary

A medical device company based in the United States is seeking a Clinical Affairs Scientist. This essential role involves data science, clinical data management, and medical writing, crucial for enhancing the understanding of investigational and commercial products. Candidates should have at least 5 years of experience in the medical device field, particularly within spine or implantable devices. The position requires proficiency in statistical tools and clinical trial management, along with the ability to communicate complex data effectively. Travel may be required up to 10%.

Qualifications

• 5+ years experience in medical device and clinical research.
• Experience in spine and/or implantable device industry preferred.
• Ability to travel up to 10%.

Responsibilities

• Lead analysis of clinical datasets to identify insights.
• Oversee data integrity and structure across studies.
• Draft and revise key clinical documents and publications.

Skills

Data analysis

Medical writing

Clinical research

Statistical software (R, SAS, Python)

Clinical trial management

Education

Masters or PhD in relevant field

Tools

Clinical Trial Management Software

Job description

NOTE: You must have 5+ years experience in medical device, clinical research, data analysis, and medical writing with a strong preference for experience in the spine and/or implantable device industry to be considered for this position.

As an integral team member of Clinical/Regulatory, the Clinical Affairs Scientist will serve a hybrid function spanning Medical Writing, Data Science, and Clinical Data Management. This role is designed for a small, agile clinical organization where cross-functional expertise is essential to maximizing the value of our clinical, bench, and real‑world evidence data sets.

The ideal candidate will help PMT deepen its understanding of our investigational and commercial product performance, identify pathways for future regulatory or marketing claims, support ongoing and new clinical studies, and lead the development of manuscripts, abstracts, and clinical documents that communicate our evidence to internal and external stakeholders.

This position will play a critical strategic role in shaping PMT’s clinical evidence generation, data exploration, and scientific communications throughout the lifecycle of our cervical and lumbar interventional spine technologies.

MAIN RESPONSIBILITIES

• Data Science & Evidence Exploration (~40%): Lead strategic analysis and exploration of PMT's clinical datasets to identify insights, claims opportunities, and research pathways.
• Conduct exploratory analyses on data from the IDE study, legacy clinical studies, real‑world evidence programs, and materials/bench testing datasets.
• Integrate multiple datasets (IDE, post‑market, legacy trials, bench data) to explore novel clinical or regulatory claims, identify signals, or highlight areas for further investigation.
• Develop analytical plans for exploratory work and hypothesis‑generative analyses, independently and with consultation/guidance from team and MT.
• Identify patterns or early signals that may support future studies, line extensions, product differentiation, or claims expansion.
• Support cross‑functional partners (Regulatory, R&D, Marketing) by translating complex data into actionable narratives or claims opportunities; utilize knowledge.
• Subject Matter Expert: Generate strategic reports and dashboards summarizing insights, trends, and opportunities discovered through advanced data exploration, and stay abreast of the competition and the clinical evidence factors that provide differentiation in the market. Remain current with regulatory requirements for medical device products.
• Clinical Data Management (~30%): Oversee data integrity, structure, and flow across all PMT studies, with hands‑on responsibilities within our bespoke Clinical Trial Management System (CTMS).
• Ensure alignment with study protocols and data collection needs.
• Manage data integrity, in tandem with study management, including eCRF builds, edit checks, user workflows, and quality control steps.
• Conduct periodic data reviews, resolving inconsistencies and ensuring GCP‑compliant data management practices.
• Develop and deliver interim data summaries and reports to support study conduct, safety monitoring, and internal decision‑making.
• Collaborate with clinical team and contractors, as appropriate, to oversee quality, timelines, and alignment with PMT study priorities.
• Contribute to data lock, freeze, transfer, and final reporting activities for PMT's new and ongoing clinical studies.
• Build signal‑detection and forecasting tools to help Clinical Affairs anticipate emerging trends or areas of attention as data accrue. Medical Writing & Scientific Communications (~30%): Serve as a key driver of PMT's clinical storytelling through high‑quality scientific and regulatory writing.
• Draft, revise, or update key clinical documents, including Clinical Investigation Plans (CIPs) / Study Protocols, ICFs, IBs, protocol amendments and updates, Clinical Study Reports.
• Develop high‑quality scientific content, including abstracts and posters for scientific congresses, peer‑reviewed manuscripts for journal submissions, and generate white papers, clinical summaries and value narratives.
• Support surgeon‑authors and key opinion leaders with writing assistance, literature searches, and data interpretation.
• Ensure consistency, accuracy, and high scientific standards across all written materials.
• Collaborate cross‑functionally to support submissions and evidence packages, as needed.
• Contribute to publication planning, scientific messaging and dissemination strategy across the organization.

QUALIFICATIONS

• Advanced degree (Masters or PhD) in a relevant field.
• Minimum five (5)+ years experience in medical device, clinical research, data analysis and medical writing. Medical device experience in spine and/or implantable device industry strongly preferred.
• Ability/willingness to travel up to 10%.
• Prior experience with clinical trial protocol development, abstract and manuscript generation.
• Experience with proprietary or custom data platforms.
• Experience working in small or mid‑sized medical device companies where versatility is essential.

REQUIRED SKILLS AND ABILITIES

• Proficient with clinical trial management software.
• Proficiency with statistical software (R, SAS, Python), even if supported by external partners.
• Expected subject matter expertise, centering on US Medical Device testing and clinical trials, and their respective regulations, guidance, and policy (i.e., experience with IDE clinical trial and international regulatory process required including FDA (e.g., 21 CFR); ICH and ISO:14155).
• Self‑motivated, team player, with excellent time management skills to impact a full range of customer, operational, and clinical service activities within the team and cross‑functionally.