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Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents. Responsible for performing data management oversight activities in support of Leap Clinical Studies by overseeing the activities of the CRO DMs, from study start-up through to study closeout, to ensure adherence to scope of work and service agreements, and that the deliverables are on time, within budget and are of a high quality.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The Sr. Grant Administrator will be responsible for the pre and post award management of a portfolio of grants and contracts within the Mass General, Ragon Institute of MGH, MIT and Harvard. ·Contribute to updating and maintenance of a centralized electronic (MGH shared drives) grants management and archiving system.
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Knowledge of the following areas: networking, cloud computing, vulnerability management, Identity and Access Management tools, Active Directory, Privileged Access Management, Multifactor Authentication and Single Sign-On concepts, baselines, security monitoring, change management, asset management, incident response, SDLC, encryption, etc.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc. Experience in project managing the deployment of IT applications relevant to the Pharma Industry, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, Laboratory Information Management Systems (LIMS), and Pharmacovigilance (PV) systems.
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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies. Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups.
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Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with Blueprint teams, CRO’s and vendors.
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Data bases (SQL, NoSQL) and Data Platforms (Databricks, Snowflake) Strong skills with Database management, Data modeling and design DevOps and Security CI/CD, Serverless compute, OAuth, SSO, MFA etc.
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Data storage, database infrastructure, and data engineering) to maintain efficient and secure management of data assets as well as application hosting. Develop and enforce best practices for IT infrastructure management, including disaster recovery, data storage, network design, and cloud services.
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Moderna is seeking an experienced, versatile, pragmatic, and dynamic Executive Director Safety Physician Leader to help lead a Clinical Safety and Risk Management (CSRM) team of physicians in the Infectious Disease Therapeutic Area. The ideal candidate will be a seasoned safety professional with extensive medical expertise, drug disease insight, regulatory knowledge, and leadership abilities in a matrix organization.
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Works in close collaboration with internal departments including Division of Academic and Public Programs, Director’s Office, Communications, Collections Management, Conservation Center, Archives, Digital Images and Visual Resources, Information Technology, and Institutional Advancement.
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Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed. Minimum of 8-10 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.
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High level of expertise in the use of the data-management software including for example Medidata RAVE. 4+ years as Clinical Data Manager with proven project management capabilities in a pharmaceutical company or in a CRO and at least one project on a neurological disease.
$112,599 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Will be responsible for overseeing the revenue generating Esports room, intramural sports risk management, and intramural sport related disciplinary issues; hiring and onboarding day camp staff and intramural officials; and performing administrative responsibilities that ensure that all club sports, intramural sports, and day camp programs have what they need to succeed.
$50,000 - $56,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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PhaseForward Inform, Oracle Clinical and/or other clinical data management software desirable;General software skills: MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries, especially MedDRA and WHODRUG.Experience applying best practices in clinical data management programming in the clinical trial environment, including requirements definition and QC plansKnowledge of GCP and other regulations.
Full-timeExpandApply NowActive JobUpdated 10 days ago
management job Company: Got Junk in Cambridge, Bentonville, Kansas
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