Senior Clinical Data Manager katalyst HLS

Primary Job Responsibilities: Create and review (electronic) Case Report Forms perProtocol and annotated Case Report Forms Review Protocols to ensure database feasibility Develop/build, review, and maintain a clinical database andsupporting specifications documentation Develop/build, document and perform validation of databasestructure, data capture screens, code lists, edit checks, reports and otherfunctions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications withvarious vendors Write, review and maintain eCRF completion guidelines, datamanagement plan (DMP), data validation plan (DVP, e.g. edit checks), and otherDM related documentation Perform all aspects of DM process as related to processingand QC of the data Clean data for study close out and perform all database lockprocedures
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Regulatory Affairs Consultant katalyst HLS

Job Description: The Regulatory Affairs Specialist is responsible for obtaining US and OUS product clearances as well as maintaining Technical Files and Establishment Licenses. Also, participants in worldwide Field Actions. In addition, the Regulatory Affairs Specialist communicates significant design changes outwardly to Distribution Partners, while also communicating changes in the evolving regulatory landscape inwardly to product development team.
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Clinical Data Analyst katalyst HLS

Job Description: Coordinate and ensure the timely completion of all Data Management activities for assigned projects following appropriate regulatory guidelines, and company and department SOPs. Provide technical and Data Management expertise as a member of a cross-functional project team. Write clinical Data Management Plans and associated documents (i.e., database specifications, data entry guidelines) and drive the project team review and approval process. Facilitate clinical trial eCRF development or other data capture processes. Design and build eCRFs in Medidata Rave including database validation checks. Oversee and/or conduct and document the User Acceptance Testing of data entry screens, database build and edit check programming. Process and manage instrument generated data including edit checks using SAS.
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Senior Quality Engineer Katalyst HLS

Job Description: The Principal Pharma Quality Engineer will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products for the Fridley CRHF (Rice Creek) Pharmaceutical Operations business. In this role, you would provide quality engineering support in sterilization management, environmental control, and cGMP pharmaceutical manufacturing of combination products including analytical lab activities. Provide support to internal and external customers, perform root cause analysis and implement corrective action. May manage projects for new or revised products or quality system changes in cGMP pharmaceutical requirement of combination products. Provides coaching on cGMP regulations and all relevant standards to Quality and Manufacturing Engineering staff. to staff. CRHF seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in o
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Veeva Vault Analyst Katalyst HLS

Requirements Veeva Vault administrator. Experience in Veeva Vault (Promomats, RIM, QualityOne) Experience working with a validated system within the life sciences industry, with 5+ years of experience Strong expertise in authoring SDLC documents and working within SDLC process Comfortable working with vendor and business users / good communication skills and relationship building abilities Act as global deployment lead for the entirety of PromoMats implementation program Own Veeva Vault PromoMats system change management process as part of operational model Manage activities of support run team, onboard and train as needed, assess run team capacity and areas where KT is needed. Assess support model and provide strategic insight on continuous process improvements.
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Regulatory Submission Specialist Katalyst HLS

DESCRIPTION: As a central eSubmissions expert, incumbent provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope. Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum). Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor. Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types. This role includes partnering with RSMP colleagues at other sites t
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Clinical Data Manager Katalyst HLS

Roles & Resposibilities: Collaborate with clients and vendors to finalize Data Transfer Agreements (DTA) Provide recommendations and alternatives to optimize data quality Perform analysis of test transfers to determine coding specifications including any data translation and mapping needs Define data mapping required to successfully import data Convey implications of data transfer inadequacies to the client Create standard data transfer format(s) in compliance with client requests while adhering to internal processes Act as a data liaison between Data Management and all other applicable departments Support data discrepancy, investigation, and resolution including root cause analysis and, if internal in nature, identification of corrective and preventative actions Oversee the integrity and maintenance of client data Participate in client-related meetings
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