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Working knowledge of EDC systems – preferably Medidata RAVE. Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
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Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform. Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred.
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Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools. Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools.
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Masters degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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Skilled in the use of data management software application, Medidata RAVE. Ensure proper completion of UAT of EDC system and modules. Review/prepare training materials and user guides for EDC data collection tools, deliver user training.
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Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. This includes all global validated applications across the Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance business units.
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Job DescriptionTakeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system. Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
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Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Conduct data management training as well as study specific training for the CDM and study teams. Oversee and participate in the process of data review and query generation procedures. Keep supervisor updated on study progress and staff management through routine meetings.
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PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
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Building a candidate pipeline through a great internship program for local college students and recent graduates at local universities is a great and cost-effective way to attract and retain top talent. By offering meaningful and impactful work experiences, regular feedback, coaching, and mentorship, you can create a positive internship experience that will make your organization a sought-after destination for future employees. This not only benefits the organization in the short-term but also in the long-term, as you'll have a pool of well-trained and experienced candidates who may be interested in full-time employment once they graduate. Furthermore, building relationships with local universities and college students can increase brand awareness and build a positive reputation for your organization in the local community.