Cardiology Clinical Data Strategist
hace 24 horas
Company Overview
\Boston Scientific is a global leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
\Job Description
\We are seeking a skilled Cardiology Clinical Data Strategist to join our team. As a key member of our clinical evaluation team, you will play a vital role in developing global evidence-based clinical strategies for cardiology medical devices (Cardiac Rhythm Management). Your expertise will help us create clinical documentation that systematically synthesizes information from multiple data sources.
\You will plan and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio cardiology devices.
\A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners. Your efforts support product approval, indication expansion, and claim support, and mandated post-market requirements.
\Responsibilities
\- \
- Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data.\
- Compare and align this data with Risk Documentation and product labeling to identify gaps or emergent concerns.\
- Develop literature search strategies in collaboration with librarians and perform methodical evaluation of medical literature including screening, appraisal, and extraction of relevant data.\
- Develop Clinical Benefit Statements in collaboration with medical experts and develop pre- and post-market data collection strategies to support the developed statements.\
- Create analyses to evaluate product benefit/risk profile, safety (e.g., develop a profile of adverse events), and performance.\
- Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.\
- Develop global clinical data strategies in collaboration with leadership and cross-functional partners to support market access for New Product Development, Sustaining Product compliance, and Design Changes to existing products.\
- Manage ongoing Design and Quality activities to support necessary changes and/or improvements to devices, including assessing the impact to existing clinical data strategies, proposing and developing new clinical data activities to meet any identified gaps, and coordinating with management to ensure resourcing needs are considered.\
- Aid in the development and execution of strategies for responses for regulatory submissions.\
Requirements
\To be successful in this role, you must have:
\- \
- A Bachelor's, Master's or Advanced degree (PhD, research-based MS, MD, RN, DVM) in a scientific, medical, or engineering field.\
- 6+ years professional experience in a scientific, engineering, medical, or medical device space with 3+ years of experience in at least one of the following: Writing and Developing Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-Up Plans/Reports in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulations), relevant Medical Device Coordination Group (MDCG) guidance, and harmonized standards.\
- Experience working in the clinical treatment and management of patients receiving Cardiac Rhythm Therapies, including but not limited to: Pacemakers; Implantable Cardioverter-Defibrillators (ICDs); Cardiac Resynchronization Therapy Pacemakers/Defibrillators (CRT-P/Ds); or Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs).\
- Writing, Developing, Managing, and Submitting Regulatory Technical Documentation submissions in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e., EU Medical Device Regulations) to support EU Market access of Cardiac Rhythm Devices.\
- Thorough understanding of different types of clinical evidence (e.g., literature, clinical trials, real-world evidence, etc.) and the benefits and limitations of each type of data.\
- Strong analytical skills, including familiarity with medical literature and advanced proficiency in English aligned with C1 level or 85-90% proficiency.\
Preferred Qualifications
\We also welcome candidates with additional experience in strategically applying knowledge of regulations, medical knowledge, and data types to develop clinical data strategies to support submission, as well as those who possess strong medical/scientific writing skills.
-
Clinical Data Analyst Intern
hace 2 meses
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoAbout Boston Scientific Corporation:We are a global leader in medical technology, dedicated to improving patient outcomes through our innovative products and solutions.Estimated Salary: $45,000 per yearJob Summary:We are seeking a highly motivated Clinical Data Analyst Intern to join our team. As a Clinical Data Analyst Intern, you will play a crucial role...
-
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo**Company Overview**: Boston Scientific Corporation is a global leader in medical device innovation, driven by a passion for improving human health. With a collaborative culture and commitment to diversity and inclusion, we empower our employees to make a meaningful difference in people's lives.**Estimated Salary:** $18-20 per hour, depending on...
-
Clinical Data Specialist
hace 2 meses
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo**Role Overview**Boston Scientific Corporation is seeking a skilled Clinical Data Specialist to join our team. As a Clinical Data Specialist, you will play a crucial role in clinical research by controlling the information collected during a clinical trial.**Key Responsibilities**Review clinical data for completeness, accuracy, and consistency in accordance...
-
Data Insights Strategist
hace 1 semana
San Francisco, Heredia, Costa Rica Tebra A tiempo completoAbout TebraTebra is a leading healthcare technology company dedicated to empowering independent medical practices to deliver exceptional patient care. Our innovative solutions help practices streamline operations, improve patient engagement, and enhance clinical outcomes.Job SummaryWe are seeking a highly skilled Data Insights Strategist to join our...
-
Data Management Specialist
hace 4 semanas
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoAbout the CompanyBoston Scientific Corporation is a global leader in medical devices and technology, dedicated to improving patient health and quality of life.Job SummaryWe are seeking an experienced Data Management Specialist to join our Clinical Research team. As a key member of our team, you will be responsible for managing clinical data, ensuring its...
-
Sales Data Strategist
hace 2 meses
San Francisco, Heredia, Costa Rica Straumann Group A tiempo completoWe are seeking a highly skilled Sales Data Strategist to join our team at the Straumann Group.**About Us**:The Straumann Group is a global leader in the field of esthetic dentistry, tooth replacement and restoration solutions. Our company has a long history of innovation, with the first dental implant being introduced in 1974.**Job Description**:We develop,...
-
Senior Data Strategist
hace 4 semanas
San Francisco, Heredia, Costa Rica Performics A tiempo completoEstimated Salary: $120,000 - $180,000 per yearAbout the Role:We are seeking a highly skilled Senior Data Strategist to join our team at Performics.Company Overview:Publicis Groupe is a global leader in advertising and marketing services, with a rich history dating back to 1926. Our company is known for its creativity, technology, and expertise in digital...
-
Data Strategist
hace 2 meses
San Francisco, Heredia, Costa Rica Performics A tiempo completoAbout the Role:La empresa líder en gestión de datos, Performics, busca un profesional experimentado como Data Strategist para liderar la estrategia de datos en el equipo.Responsabilidades:· Planificar y implementar estrategias de datos para mejorar la toma de decisiones empresarial.· Desarrollar recomendaciones basadas en análisis de datos para mejorar...
-
Senior Data Insights Strategist
hace 4 semanas
San Francisco, Heredia, Costa Rica Databricks A tiempo completoJob SummaryWe are seeking an experienced Senior Data Insights Strategist to join our team at Databricks. This is a full-time position based in San Francisco, with the opportunity to work remotely.About the RoleThe successful candidate will be responsible for driving business recommendations by analyzing and extracting meaningful insights from large and...
-
Data Insights Strategist
hace 6 días
San Francisco, Heredia, Costa Rica Philip Morris International A tiempo completo**Company Overview:**We are a multinational tobacco company that is driving transformation and innovation in the industry.**Job Description:As a Data Insights Strategist, you will be responsible for identifying patterns and areas for improvement in sales activities for our CARICOM Cluster. This includes developing reports and dashboards with full KPI...
-
Chief Data Insights Strategist
hace 4 semanas
San Francisco, Heredia, Costa Rica Moody'S A tiempo completoMoody's is a global leader in integrated risk assessment, empowering organizations to make informed decisions.**Job Summary:**We are seeking an experienced Chief Data Insights Strategist to join our team. In this role, you will be responsible for supporting the execution of data and analytics requests from the Finance organization.You will facilitate...
-
Financial Data Strategist
hace 2 meses
San Francisco, Heredia, Costa Rica Experian A tiempo completoAbout UsAs a global leader in information, analytical and marketing services, Experian unlocks data to create opportunities for consumers, businesses and society.We empower consumers and clients to manage data with confidence, maximizing every opportunity by gathering, analyzing and processing data in ways others can't.We help individuals take financial...
-
Data Insights Strategist
hace 2 meses
San Francisco, Heredia, Costa Rica Experian A tiempo completoAbout ExperianExperian is a leading global information services company that empowers consumers and clients to manage data with confidence. Our mission is to help individuals take financial control, businesses make smarter decisions, lenders lend responsibly, and organizations prevent identity fraud.We have a team of 20,000 people operating across 44...
-
San Francisco, Heredia, Costa Rica Experian A tiempo completoJob SummaryWe are seeking a highly skilled Data Product Strategist to join our team in the North American market. As a key member of our Product team, you will be responsible for driving revenue growth and developing product strategies that meet the needs of our clients.The ideal candidate will have 2-4+ years of experience in product management or...
-
Data Insights Strategist
hace 3 semanas
San Francisco, Heredia, Costa Rica Jll A tiempo completoJob DescriptionAt JLL, we are committed to supporting the Whole You, personally and professionally. As a Business Intelligence Domain Owner, you will play a crucial role in delivering modern BI Solutions to our customers.About the RoleYou will be responsible for working closely with customers in your domain to ensure they receive the reports, dashboards, and...
-
Data-Driven Sales Strategist
hace 2 meses
San Francisco, Heredia, Costa Rica Straumann Group A tiempo completo**Unlock Your Potential with Straumann Group**We are a pioneering company in the field of esthetic dentistry, driven by innovation and a passion for making a difference. With a rich history dating back to 1974, we have established ourselves as a leader in developing, manufacturing, and supplying dental implants, clear aligners, instruments, CADCAM...
-
Talent Acquisition Strategist
hace 3 semanas
San Francisco, Heredia, Costa Rica Ibm Careers A tiempo completoJob TitleTalent Acquisition StrategistAbout the RoleWe are seeking a highly skilled and experienced Talent Acquisition Strategist to join our team. As a Recruiting Selection Specialist, you will have the opportunity to execute on various recruiting strategies to identify, screen and deliver high-quality, diverse talent to meet business hiring...
-
Senior Customer Experience Strategist
hace 3 semanas
San Francisco, Heredia, Costa Rica Aligntech A tiempo completoUnlock a world of opportunities at Aligntech, where innovation meets excellence.Aligntech is revolutionizing the dental and orthodontic industry with its cutting-edge technology. As a Senior Customer Experience Strategist or Customer Experience Operations Manager, you will play a vital role in shaping the future of customer service.Estimated Salary: $120,000...
-
Data-Driven Digital Marketing Strategist
hace 24 horas
San Francisco, Heredia, Costa Rica Bairesdev A tiempo completoBairesDev is a leading technology company in Latin America, recognized for its fast growth and commitment to being a welcoming employer (Glassdoor Employee Score: 4.3).We have over 3500 employees across 27 countries, working with world-class clients from start-ups to Fortune 500 companies. Our strength lies in our multicultural teams.To deliver high-quality...
-
Data Strategist
hace 3 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoUnlock Career Opportunities at ExperianWe are a leading global information services company, empowering consumers and clients to manage their data with confidence. Our mission is to help individuals take financial control, businesses make smarter decisions, and organizations prevent identity fraud.As a Data Strategist in our Credit Services team, you will...
