Overview: The Genomics Research Canter (GRC) is a centre of excellence for genetics and genomics that supports both Discovery and Development. The GRC plays an integral role towards our goal of developing extraordinary genetics and genom...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, e...
Responsibilities and Requirements: Must be from Life science or Pharma domain experience. He should be capable of managing 10+ members team. 7+ years of total IT experience out of which 5+ years of experience in Compute...
Responsibilities: Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external cl...
Responsibilities: Responsible for the overall development life cycle of the solution and manage complex projects with significant bottom line impact. Instill best practices for portfolio documentation, ensure designs meet requirements, ...
Responsibilities: Hands on CDISC/SDTM/ADaM experience. Training or experience using the OMOP common data model. Training or experience with Python, R, Databricks or other cloud-based software. Pharmaceutical industry experience. Train...
Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validat...
Job Description: As Principal Engineer, Early Process Design and Development in Lake Forest, CA the ideal candidate will be a senior member of a high performing team, specialized in the design and development of processes, fixtures and tes...
Responsibilities: Master's degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content. Hands on CDISC/SDTM/ADaM experience. Training or experience using the OMOP common data model. Traini...
Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...
Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...
Job Description Expert in CSA validation principles. Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. Developing, reviewing, and executing testing documentation. Direct experience a...
Responsibilities: Perform tasks identified as part of the overall project plan including, but not limited to Planning, development, and implementation of analytical TMV-related documentation such as validation plans, validation protocols...
Responsibilities and Requirements: Resource should be an expert in validation and compliance of Pharma processes, active involvement in qualification and documentation of applications and tools. Skills Required: Quality Assurance, Compl...
Responsibilities: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and anal...
Responsibilities: Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data M...
Job Description The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin b...
Specific Job Responsibilities Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufactur...
Responsibilities and Requirements : The client has deliverables coming up and needs a consultant to help hit specific deadlines. This role is a combo device position, the consultant is required to have experience with prefilled syringes,...
Top 3 skills: Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufactu...