Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience. * 6+ years of Clinical Data ...
Katalyst Healthcares & Life Sciences
78 jobs near Decatur, GA
Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience. * 6+ years of Clinical Data ...
Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle ... BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field ...
Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle ... BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field ...
Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. * 5+ years of experience in regulatory affairs within the pharmaceutical or ...
Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. * 5+ years of experience in regulatory affairs within the pharmaceutical or ...
Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields * Advanced SAS macro programming experience is ...
Sc., M.Sc., or equivalent education in Biostatistics/Statistics, Bioinformatics, Life Sciences, Mathematics, Physical Sciences, or related fields * Advanced SAS macro programming experience is ...
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. * 2-5 years Medical Device experience. * Working knowledge of ...
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. * 2-5 years Medical Device experience. * Working knowledge of ...
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. * 2-5 years Medical Device experience. * Working knowledge of ...
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. * 2-5 years Medical Device experience. * Working knowledge of ...
D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. * 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry. * Demonstrated ...
D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. * 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry. * Demonstrated ...
S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry * 2-5 years Medical Device experience * Working knowledge of industry ...
S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry * 2-5 years Medical Device experience * Working knowledge of industry ...
Senior Quality Control Specialist
$87.30K - $120.20K/yr
Requires bachelor's degree in science, engineering or other related technical field. * 4+ years of related experience in pharmaceutical or similar regulated industry. * Strong QC Microbiology ...
Senior Quality Control Specialist
$87.30K - $120.20K/yr
Requires bachelor's degree in science, engineering or other related technical field. * 4+ years of related experience in pharmaceutical or similar regulated industry. * Strong QC Microbiology ...
Bachelor of Science (BS) degree with 7-10 years of clinical data management experience. * Extensive knowledge of EDC systems, CDISC standards, and data visualization tools. * Proven experience ...
Bachelor of Science (BS) degree with 7-10 years of clinical data management experience. * Extensive knowledge of EDC systems, CDISC standards, and data visualization tools. * Proven experience ...
Bachelor's degree in a health-related, scientific, or equivalent field. * 8 years of experience in Clinical Data Management role. * Strong understanding of Standard Operating Procedures (SOPs), Good ...
Bachelor's degree in a health-related, scientific, or equivalent field. * 8 years of experience in Clinical Data Management role. * Strong understanding of Standard Operating Procedures (SOPs), Good ...
Sr. Product Quality Engineer
$85.10K - $115.40K/yr
* The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. * Responsible for maintaining a strong collaborative ...
Sr. Product Quality Engineer
$85.10K - $115.40K/yr
* The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. * Responsible for maintaining a strong collaborative ...
* The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. * Responsible for maintaining a strong collaborative ...
* The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. * Responsible for maintaining a strong collaborative ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
Job Summary: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design ...
Job Summary: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
* This position is Non-exempt. Hours over 40 will be paid at Time and a Half. * The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product ...
* This position is Non-exempt. Hours over 40 will be paid at Time and a Half. * The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product ...
Operator 1, Warehouse Operations
$14.25 - $17.25/hr
RESPONSIBILITIES * The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. * The omission of ...
Operator 1, Warehouse Operations
$14.25 - $17.25/hr
RESPONSIBILITIES * The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. * The omission of ...
Laboratory Technician
$20.25 - $26.75/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. * We have a few immediate ...
Laboratory Technician
$20.25 - $26.75/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. * We have a few immediate ...
NPD Test Lead
$51.75 - $70.50/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. * We have a few immediate ...
NPD Test Lead
$51.75 - $70.50/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. * We have a few immediate ...
Job description
Responsibilities:
- Maintain and update EDC user access across multiple clinical studies
- Track and manage user access requests in coordination with CRAs and EDC vendors
- Curate and maintain standardized tracking spreadsheets for both internal and external use
- Transfer verified data from working trackers to production master user lists
- Respond to and resolve user-related queries from study teams and EDC builders
- Prepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standards
- Track document status and ensure completeness and accuracy of TMF content
- Collaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely manner
- Assist with study startup, maintenance, and closeout CDM activities as needed
- Participate in team meetings, training sessions, and cross-functional collaboration
- Support documentation and version control for CDM tools and templates
- Maintain clear and organized records of work performed
- All other duties as assigned
- Bachelor's degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
- 6+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
- Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently
- Ability to work effectively in a team-oriented environment
- Flexibility to adapt to changing project requirements and timelines
- Excellent attention to detail and organizational skills
- Strong communication and collaboration abilities
- Proficiency in Microsoft Excel, Word, and document management tools
- Strong organizational skills to manage multiple tasks and projects simultaneously
- Preferred :
- Experience with EDC systems (e.g., Medidata Rave, Oracle InForm)
- Familiarity with TMF structure and regulatory filing practices
- Understanding of GCP, GCDMP, and clinical trial workflows
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US