Roles & Responsibilities: The ideal candidate will have 7-8 years of validation experience and at least 3 in Salesforce Validation. Seeking a CSV resource who has experience specifically with Salesforce. They are currently seeking a Sr....
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
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: Responsible for managing end-to-end CSV deliverables for both new & existing applications. Draft documents, QA Review of the following CSV Deliverables: User Requirements, SOPs Application Administrative Tasks & Protoco...
Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). If applicable, develops and provides department training for applications and standa...
Qualifications: - Providing the validation strategy for different computer systems in life sciences industry - Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective. - Comprehensi...
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
Responsibilities: Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects. Take Quality ownership, participate in cross functional team...
Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards ar...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), C...
Responsibilities: Provide programming support for study deliverables as assigned, ensuring that timelines are met and expected quality is attained. Liaise with Data Management and Biostatistics for database and dataset specifications, ti...
Responsibilities: Provide programming support for study deliverables as assigned, ensuring that timelines are met and expected quality is attained. Liaise with Data Management and Biostatistics for database and dataset specifications, ti...
Responsibilities: Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software dev...
Responsibilities: Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality. Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i...
Responsibilities: Develop and implement quality plans and strategies aligned with project and organizational goals. Identify areas for improvement in manufacturing and engineering processes, applying methodologies like Six Sigma or Lean....
Responsibilities: This CSV Lead will be working with the application configurators to document the processes and workflow. Identifying risks-based approach to their validation process; future enhancements, upgrades, workflow mods, etc. ...
Responsibilities: NTFS permissions. Excellent written and verbal communication. Service now, Veeva, track wise, Active Directory, firewall rules, My Access, Applications impacted by upgrades; Idele candidate should have previous exper...
Responsibilities: Client collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, ...
Responsibilities: Lead programming activities and provide input on programming methodologies to support the clinical development process. Program and/or validate tables, listings, figures, and analysis datasets in response to regulatory ...
Responsibilities: Participates in requirements and design sessions, then develops and implements new system components or fixes to resolve system defects using business intelligence software and related tools. Reads and understands busin...