Senior Validation Engineer
Blacklick, OH · On-site
Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management * Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data ...
67 Katalyst Senior Clinical Data Manager Jobs Hiring Near You
Senior Validation Engineer
Blacklick, OH · On-site
Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management * Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data ...
Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and ... Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP ...
We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and ... Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP ...
CSV Engineer
Columbus, OH · On-site
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review. * Manage system change control, deviations ...
CSV Engineer
Columbus, OH · On-site
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review. * Manage system change control, deviations ...
Design Engineer L2
Raymond, OH · Hybrid
BOM Price and Weight targets management. * Other miscellaneous tasks as needed. Client Division Inputs: * Reference CAD data of previous program and similar programs. * Class A surface. * Guidance ...
Design Engineer L2
Raymond, OH · Hybrid
BOM Price and Weight targets management. * Other miscellaneous tasks as needed. Client Division Inputs: * Reference CAD data of previous program and similar programs. * Class A surface. * Guidance ...
Software Engineer L1
Raymond, OH · On-site
Supplier Management: * Learn methods to direct the Honda selected software integration partner ... data. * Requirements Capture and Specification Development * Write draft proposals, develop, and ...
Software Engineer L1
Raymond, OH · On-site
Supplier Management: * Learn methods to direct the Honda selected software integration partner ... data. * Requirements Capture and Specification Development * Write draft proposals, develop, and ...
C&Q Engineer
New Albany, OH · On-site
Manage punch list identification, tracking, and resolution through to system acceptance and ... Maintain accurate and complete C&Q records in compliance with site documentation standards and data ...
C&Q Engineer
New Albany, OH · On-site
Manage punch list identification, tracking, and resolution through to system acceptance and ... Maintain accurate and complete C&Q records in compliance with site documentation standards and data ...
The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity ...
The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity ...
Senior Clinical Data Manager
Malvern, PA · On-site
Position Summary The Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical data management team. This individual will lead data management efforts, oversee quality data ...
Senior Clinical Data Manager
Malvern, PA · On-site
Position Summary The Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical data management team. This individual will lead data management efforts, oversee quality data ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
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The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager will lead clinical data management activities for Repertoire-sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission ...
The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine ...
The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine ...
The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine ...
The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine ...
What the Senior Clinical Data Manager does at Worldwide Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and ...
What the Senior Clinical Data Manager does at Worldwide Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close * This includes the EDC build and user acceptance ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close * This includes the EDC build and user acceptance ...
Senior Clinical Data Manager
Bridgewater, NJ · On-site +1
$90K - $130K/yr
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for ...
Senior Clinical Data Manager
Bridgewater, NJ · On-site +1
$90K - $130K/yr
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for ...
Report project status and escalate study-related issues to senior leadership Requirements: * Bachelor of Science degree with 10+ years of clinical data management experience * Proficiency in EDC ...
Report project status and escalate study-related issues to senior leadership Requirements: * Bachelor of Science degree with 10+ years of clinical data management experience * Proficiency in EDC ...
Senior Clinical Data Manager
Boston, MA · On-site
$130K - $196K/yr
Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start-up through close-out. Reporting to the Director of Clinical Data Sciences, you'll ...
Senior Clinical Data Manager
Boston, MA · On-site
$130K - $196K/yr
Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start-up through close-out. Reporting to the Director of Clinical Data Sciences, you'll ...
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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Job description
Roles & Responsibilities:
- Lead/Support a Veeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout
- Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs
- Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needs
- Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution
- Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained
- Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation
- Participate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementation
- Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution
- Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles
- Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
- 5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments
- Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
- Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity
- Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports
- Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles
- Strong project management, organizational, communication, and problem-solving skills