. Bachelor's or Master's in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar. Experience..., review, and approve GxP Computerized Systems Validation life cycle and Change Control documents. Qualifications: 10...
execution. Worked in Life Sciences vertical both GxP and non GxP space. Familiar with Life science business process flow... with hands on testing deliverables. 5 years Hands On - POMS MES and Integration in Life Sciences. 2 years Life Sciences...
results. Education And Experience: Degree in health or life sciences, including chemistry, molecular biology, or similar... to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities. The Company...
platforms). Requirements: Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field. 7...
Job Description: We are seeking a Validation Lead / Test Lead with strong experience in Life Sciences... or life sciences projects. Responsibilities: Lead validation and testing teams across onshore/offshore environments...
: Bachelor's degree in life sciences, healthcare, information technology, or related field. 1-3 years of experience in clinical...
's or master's degree in Immunology, Cell Biology or a related Biological Sciences field, with 3-5 years of relevant hands...
's or master's degree in Immunology, Cell Biology or a related Biological Sciences field, with 3-5 years of relevant hands...
environment. Requirements: Bachelor's or master's degree in Biological Sciences, Immunology, or a related field. 2-3 years...: Bachelor's (3+ years' work experience) or master's degree (1+ years') in biological sciences. Training or work...
of regulatory responses and may participate in meetings. Requirements: Bachelor's degree in the sciences; advanced degree (e.g...
clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Cre...
Roles & Responsibilities: Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities. Create external data transfer agree...
Summary : Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Qual...
Job Description: We are currently seeking a highly motivated and passionate scientist to join our team in Immunology Discovery department based in Cambridge MA. The candidate will focus on generating biology data packages to help advance t...
Responsibilities: Lead clinical data management activities for pivotal trials, ensuring data quality and integrity Collaborate with cross-functional teams to support clinical trial data management processes Oversee vendor management and...
Responsibilities: Generate, execute, review, finalize, and approve validation/qualification protocols and reports. Manage and update project validation plans for specific projects. Assist and deliver amendments to the qualification(s) t...
Responsibilities: Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submissio...
Job description: We are currently seeking a highly motivated and passionate scientist to join our team in Immunology Discovery based in Cambridge MA. In this role, the candidate will collaborate with multiple cross-functional teams to adva...