cGxPServe

Responsibilities: Troubleshooting MATLAB compatibility issues with laptop Security/antivirus software: installation activation configuration and license management issues. Troubleshooting and resolving technical issues including those involving cloud platforms (like AWS and Azure Git More...

Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content review of edit check specifications and perform user acceptance test More...

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable More...

Responsibilities: Responsibilities include developing regulatory strategies reviewing design input/output documentation identification of applicable standards and guidance documents performing regulatory assessments to determine the impact of design/process changes preparing regulato More...

Roles & responsibilities: Our client is looking for a Lab Vantage LIMS Admin. They are utilizing version 8.6 to support and maintain their laboratory informatics systems within a regulated GMP pharmaceutical environment. The ideal candidate will manage user support and compliance act More...

Responsibilities: Collaborate at a systems level with R&D Clinical Data Analysis and other key functions to develop a quantitative approach to risk management. Lead cross-functional teams to identify risks implement risk control measures and document a robust and living Risk Manageme More...

Responsibilities: Develop targeted study-specific SDTM and Adam dataset checks Perform independent QC from raw data to Adam of primary and key secondary endpoints Deliver programming results for ad-hoc analysis requests Collaborate with data management and their programming team to e More...

Responsibilities: Follow all company safety rules regulations and job safety analyss. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited. Discarding obviou More...

Responsibilities: Support the end-to-end clinical data management process for assigned studies from protocol review to database lock. Collaborate with cross-functional teams including clinical operations biostatistics and medical writing to define data collection and reporting needs. More...

Job Description: The Design Quality Engineer I will be responsible for developing quality assurance documentation to support new product development and regulatory submissions. This role requires maintaining the quality system for the design control process by identifying and correct More...

Responsibilities: Main responsibility includes design of Case Report Forms development of edit check specifications creation of test scripts and testing of study database query processing data reporting putting in place data management plans timelines and manage multiple projects thr More...

Responsibilities: Performing data manipulation analysis and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files and tables listings and figures (TLFs). Production and QC More...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Job Description: Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manu More...

Responsibilities: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management Sy More...

Responsibilities: Leads the statistical programming activities for projects with lower complexity. Leads the statistical programming activities for studies. Develop SAS programs for the creation of Adam data sets following CDISC standards. Develop SAS programs for the creation of Tab More...

Job Description: We are seeking a highly skilled Bioinformatics Data Analyst to join our team. The ideal candidate will be responsible for retrieving managing and visualizing large datasets while developing custom applications and the integration of laboratory equipment. Responsibilit More...

Responsibilities: In this role you will perform specialized level work assignments and/or analyses evaluation preparation and submission of documentation for regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary regu More...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: Collaborate with data managers statistical programmers biostatistics clinical operations and external vendors to review sign off on the data transfer specifications and transfer data from external sources ensuring data is received and validated for data integrity. C More...