EDC Validation Resource
3 months ago
Description:
· Senior Validation resource (CSV) with experience in UAT, Library and data listings.
· EDC Validation experience required.
· Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process.
· Experience in UAT, Library and data listings.
· Must have experience with HP Client-ALM.
· Review of URS document and understand the functionality.
· Responsible for all the validation deliverables as per. compliance.
· Enable change management at the customer, based on change management recommendations.
· Draft, review and execute the IQ/OQ (Test Protocols) scripts.
Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
\r
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
-
Sas Programmer with clinical
3 months ago
Boston, United States Elajika com Full timeExperience; 2+Duration; 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets define.xml SDRG Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client SDTM automation tools macros and using them for SDTM...
-
Sas Programmer with clinical
3 months ago
Boston, Massachusetts, United States Elajika Full timeExperience; 2+Duration; 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets SDRG Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client SDTM automation tools macros and using them for SDTM programming Strong...
-
Statistical Programmer/Data Analyst RECOVER
1 month ago
Boston, Massachusetts, United States Massachusetts General Hospital Full timeMassachusetts General Hospital (MGH) Biostatistics is seeking a Statistical Programmers/Data Analysts to join our team working on the National Institutes of Health (NIH) sponsored RECOVER project, an initiative to understand, prevent, and treat the long-term complications of SARS-CoV-2 infection. Mass General Brigham (MGB) is partnering with the NIH to...
-
IDMC Data Architect
4 weeks ago
Boston, United States Softworld, a Kelly Company Full timeJob Title: IDMC Data ArchitectJob Location: Dorchester MA 02125Onsite Requirements:CDGCEDC/AxonMust have experience migrating EDC/Axon to CDGC.Job Description: Informatica IDMC Admin required to drive implementation of Informatica Cloud Data Governance and Catalog (CDGC) on Informatica Data Management Cloud (IDMC), and migration of on-prem Informatica...
-
IDMC Data Architect
4 weeks ago
Boston, United States Softworld, a Kelly Company Full timeJob Title: IDMC Data ArchitectJob Location: Dorchester MA 02125Onsite Requirements:CDGCEDC/AxonMust have experience migrating EDC/Axon to CDGC.Job Description: Informatica IDMC Admin required to drive implementation of Informatica Cloud Data Governance and Catalog (CDGC) on Informatica Data Management Cloud (IDMC), and migration of on-prem Informatica...
-
Sr. SAS Clinical Programmer
2 months ago
Boston, United States Elajika Inc Full timeJob Title Sr. SAS Clinical ProgrammerLocation Boston MAExperience 2+Duration 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets define.xml SDRG Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client...
-
Sr. Validation Engineer
2 months ago
Boston, United States Barry-Wehmiller Companies Inc Full timeAbout Us: Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry...
-
Specialist, Regulatory Validation
1 month ago
Boston, Massachusetts, United States Northern Trust Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Specialist, Regulatory Validation
1 month ago
Boston, United States Northern Trust Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world’s most successful individuals, families, and institutions by remaining true to our enduring...
-
Regulatory Validation Audit Specialist
3 days ago
Boston, United States Northern Trust Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world’s most successful individuals, families, and institutions by remaining true to our enduring...
-
CQV/Validation Engineer
1 month ago
Boston, United States AM Technical Solutions, Inc Full timeCQV/Validation Engineer (cGMP – Pharmaceutical)Multiple Locations - USASummary:AM Technical Solutions is looking for multiple CQV resources to support major projects for various pharmaceutical clients in the US. This individual will write and execute validation protocols for new and existing, facility utilities, and process equipment.AMTS has opportunities...
-
Desktop Support/ Lab Computing Analyst
1 week ago
Boston, United States VALIDATION ASSOCIATES LLC Full time $30 - $35Job DescriptionJob DescriptionPosition Overview:Applies professional-level technical skill and judgment to provide non-routine technical support for computer/data center operations. Installs, configures and troubleshoots server and non-desktop computer hardware, software, systems and other resources in a data center or other centralized computer network...
-
Desktop Support Lab Computing Analyst
1 week ago
Boston, United States VALIDATION ASSOCIATES LLC Full timePosition Overview: Applies professional-level technical skill and judgment to provide non-routine technical support for computer/data center operations. Installs, configures and troubleshoots server and non-desktop computer hardware, software, systems and other resources in a data center or other centralized computer network setting. Maintains access...
-
Desktop Support/ Lab Computing Analyst
1 week ago
Boston, United States VALIDATION ASSOCIATES LLC Full time $30 - $35Job DescriptionJob DescriptionPosition Overview:Applies professional-level technical skill and judgment to provide non-routine technical support for computer/data center operations. Installs, configures and troubleshoots server and non-desktop computer hardware, software, systems and other resources in a data center or other centralized computer network...
-
Energy Efficiency Outreach Representative
1 month ago
Boston, United States Resource Innovations Full timeResource Innovations is seeking an Energy Efficiency Account Representative to join our growing team in Massachusetts. This position will put you on the front lines of making impactful and sustainable change through the adoption of energy efficient technologies. As an Energy Efficiency Account Representative, you will act as a key contact working with...
-
Validation Engineer
2 months ago
Boston, United States DPS Group LLC Full timeSummary The CQV Engineer will report to the CQV Manager to execute Commissioning, Qualification and Validation activities for a client in the Boston, MA area. The ideal candidate will be responsible for executing CQV activities at the new facility and to collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle...
-
Energy Efficiency Account Representative
3 months ago
Boston, United States Resource Innovations Full timeJob DescriptionJob DescriptionResource Innovations is seeking an Energy Efficiency Account Representativeto join our growing team in Massachusetts. This position will put you on the front lines of making impactful and sustainable change through the adoption of energy efficient technologies. As an Energy Efficiency Account Representative you will act as a key...
-
Energy Efficiency Account Representative
3 weeks ago
Boston, United States Resource Innovations Full timeJob DescriptionJob DescriptionResource Innovations is seeking an Energy Efficiency Account Representativeto join our growing team in Massachusetts. This position will put you on the front lines of making impactful and sustainable change through the adoption of energy efficient technologies. As an Energy Efficiency Account Representative you will act as a key...
-
Senior CRAs
4 weeks ago
Boston, United States RBW Consulting Full timeAn innovative medical device business near Boston, Massachusetts require a number of Senior CRAs to manage sites across the US. The company is running a pivotal trial for an innovative implantable device which will massive reduce the instances of stroke. They have substantial funding and have built clinical trial sites across the US and in Europe. They...
-
Senior CRAs
2 days ago
boston, United States RBW Consulting Full timeAn innovative medical device business near Boston, Massachusetts require a number of Senior CRAs to manage sites across the US. The company is running a pivotal trial for an innovative implantable device which will massive reduce the instances of stroke. They have substantial funding and have built clinical trial sites across the US and in Europe. They...