Clinical data manager
Omaha, NE · On-site
This position offers an exciting opportunity to contribute to innovative medical research that impacts patient care worldwide. Responsibilities: * Lead the design, development, and implementation of ...
60 Katalyst Medical Research Jobs Hiring Near You
Clinical data manager
Omaha, NE · On-site
This position offers an exciting opportunity to contribute to innovative medical research that impacts patient care worldwide. Responsibilities: * Lead the design, development, and implementation of ...
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Tempe, AZ · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Tempe, AZ · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Sacramento, CA · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Sacramento, CA · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Tempe, AZ · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
R&D Engineer
Tempe, AZ · On-site
Lead process development, characterization, and validation for medical device R&D. * Design and ... Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
Senior R&D Project Engineer
Irvine, CA · On-site
$105K - $136K/yr
* We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects ... The ideal candidate will possess strong project management skills, medical device product ...
Senior R&D Project Engineer
Irvine, CA · On-site
$105K - $136K/yr
* We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects ... The ideal candidate will possess strong project management skills, medical device product ...
R&D Project Lead
Raritan, NJ · On-site
Experience in medical device R&D, regulatory, or quality roles. * Proven experience leading cross-functional projects. * Hands-on experience with EU MDR requirements. * Exposure to EUDAMED ...
R&D Project Lead
Raritan, NJ · On-site
Experience in medical device R&D, regulatory, or quality roles. * Proven experience leading cross-functional projects. * Hands-on experience with EU MDR requirements. * Exposure to EUDAMED ...
Senior R&D Project Engineer
Irvine, CA · On-site
$105K - $137K/yr
The ideal candidate will possess strong project management skills, medical device product ... Conduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and ...
Senior R&D Project Engineer
Irvine, CA · On-site
$105K - $137K/yr
The ideal candidate will possess strong project management skills, medical device product ... Conduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and ...
R&D Test Engineer
Irvine, CA · On-site
The R&D Test Engineer will support the development, automation, and optimization of test methods for medical device components and prototype systems. * This role involves building automated test ...
R&D Test Engineer
Irvine, CA · On-site
The R&D Test Engineer will support the development, automation, and optimization of test methods for medical device components and prototype systems. * This role involves building automated test ...
R&D Engineer
San Jose, CA · On-site
We are seeking an innovative and detail-oriented R&D Engineer to support the research, design ... Experience in Medical Devices, Biotechnology, Life Sciences, Aerospace, Automotive, Consumer ...
R&D Engineer
San Jose, CA · On-site
We are seeking an innovative and detail-oriented R&D Engineer to support the research, design ... Experience in Medical Devices, Biotechnology, Life Sciences, Aerospace, Automotive, Consumer ...
... Contract Research Organization (CRO) selection and management, selection and training of ... Medical Device Experience * Attention to Detail * Great Communication Skills * Phase IV Experience
... Contract Research Organization (CRO) selection and management, selection and training of ... Medical Device Experience * Attention to Detail * Great Communication Skills * Phase IV Experience
R&D Engineer
Carlsbad, CA · On-site
Compiles, analyses, and reports operational, test, and research data to establish performance ... Experience within a regulated industry, particularly medical devices, is advantageous.
R&D Engineer
Carlsbad, CA · On-site
Compiles, analyses, and reports operational, test, and research data to establish performance ... Experience within a regulated industry, particularly medical devices, is advantageous.
... medical device environment. Roles & Responsibilities: * Support systems engineering activities ... Develop design concepts and research methodologies aligned with business and user needs * Create ...
... medical device environment. Roles & Responsibilities: * Support systems engineering activities ... Develop design concepts and research methodologies aligned with business and user needs * Create ...
Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, Data ...
Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, Data ...
Senior Medical Device Quality & Compliance Engineer
Santa Clara, CA · On-site
$103K - $140K/yr
Collaborate with R&D, Manufacturing, Operations, Marketing, and Quality teams to deliver compliant ... Medical Device Directive (MDD) and Medical Device Regulation (MDR) * Design Transfer Activities ...
Senior Medical Device Quality & Compliance Engineer
Santa Clara, CA · On-site
$103K - $140K/yr
Collaborate with R&D, Manufacturing, Operations, Marketing, and Quality teams to deliver compliant ... Medical Device Directive (MDD) and Medical Device Regulation (MDR) * Design Transfer Activities ...
Experience working closely with clinicians, clinical engineers, or medical affairs teams. Requirements: * Bachelor's degree in engineering or related technical field (mechanical, biomedical, or ...
Experience working closely with clinicians, clinical engineers, or medical affairs teams. Requirements: * Bachelor's degree in engineering or related technical field (mechanical, biomedical, or ...
We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D → Pilot Manufacturing → Production. The ideal candidate is a strong ...
We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D → Pilot Manufacturing → Production. The ideal candidate is a strong ...
We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating ...
We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating ...
R&D Engineer
Chicago, IL · On-site
Strong experience in medical device development within a design controls environment. * Experience with catheter-based and/or single-use medical devices. * Proven ability to lead technical ...
R&D Engineer
Chicago, IL · On-site
Strong experience in medical device development within a design controls environment. * Experience with catheter-based and/or single-use medical devices. * Proven ability to lead technical ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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What are the most popular jobs at Katalyst?
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Job description
Job Description:
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will drive the success of our clinical development programs by coordinating data activities across multiple studies, supporting research teams, and ensuring adherence to industry best practices. This position offers an exciting opportunity to contribute to innovative medical research that impacts patient care worldwide.
Responsibilities:
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will drive the success of our clinical development programs by coordinating data activities across multiple studies, supporting research teams, and ensuring adherence to industry best practices. This position offers an exciting opportunity to contribute to innovative medical research that impacts patient care worldwide.
Responsibilities:
- Lead the design, development, and implementation of data collection tools and databases aligned with study protocols and CDISC standards.
- Supervise data management activities across multiple clinical trials, ensuring timely and accurate data entry, validation, and reconciliation.
- Review source documents and case report forms (CRFs) meticulously for completeness, consistency, and compliance with regulatory requirements such as FDA regulations and ICH GCP guidelines.
- Collaborate closely with clinical research teams to monitor patient data collection processes, including vital signs, blood sampling, and patient monitoring activities.
- Oversee the review of laboratory reports, EMR systems integration, and other clinical documentation to maintain high-quality data standards.
- Ensure adherence to HIPAA regulations and maintain confidentiality of patient information throughout all data management procedures.
- Utilize statistical software tools for data analysis support and prepare datasets for statistical review and reporting.
- Manage documentation workflows, including audit trails, protocol amendments, and regulatory submissions to ensure compliance with FDA regulations and ICH GCP standards.
- Provide supervision and mentorship to junior staff or contract personnel involved in data management activities.
- Support clinical laboratory activities by understanding blood sampling procedures, phlebotomy protocols, and analysis skills necessary for accurate data interpretation.
- Proven supervising experience in clinical trial environments with a strong understanding of clinical trials management processes.
- Extensive knowledge of medical terminology, clinical research methodologies, and regulatory frameworks such as FDA regulations and ICH GCP guidelines.
- Proficiency in data collection methods using EMR systems, electronic data capture (EDC) platforms, and CDISC standards for data formatting.
- Strong documentation review skills with attention to detail in source documents, case report forms (CRFs), lab reports, and other clinical records.
- Experience monitoring patient safety parameters including vital signs and blood sampling procedures within clinical trials.
- Familiarity with statistical software packages used in clinical research for data analysis purposes.
- Knowledge of clinical laboratory procedures related to blood sampling, phlebotomy techniques, and blood sample handling.
- Ability to manage compliance requirements related to HIPAA privacy rules while handling sensitive health information.
- Excellent analysis skills for identifying discrepancies or inconsistencies in complex datasets; capable of troubleshooting issues proactively.
- Understanding of research protocols involving clinical development phases from early-phase studies through late-stage trials.