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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SAS Clinical Programmer Katalyst HLS

Roles & Responsibilities: Prepare SDTM and ADaM datasets per CDISC guidelines and programming specifications Write or modify SAS programs to generate datasets, tables, listings, and figures Develop SAS macros and templates including coding and testing Create and maintain programming documents; document changes to SAS code, programs, specifications Identify and edit checks for ongoing trials to identify study conduct or data quality issues Analyze SAS code for corrections, enhancement Familiarity with ODS outputs, PROC REPORT, PROC TEMPLATE
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Medical Devices Engineer KATALYST HLS

Job Description: Support new product design, development and implementation of delivery devices and Client injection tools/aids for biologic therapeutics. Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges. Execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various medical device designs. This will include the execution of routine and ongoing R&D stability testing, design verification testing, complaint investigations and special testing requests. Work with design engineers and the medical device development laboratory manager to identify, develop, implement, qualify and validate new testing equipment.
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Clinical Trials Manager KATALYST HLS

Job Requirements: BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred Seven or more years of relevant clinical trials experience, with at least four years of experience as a travelling CRA in the pharmaceutical industry 1+ years of trial management experience Experience in CNS required Travel required up to 20-25% of the time Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations Demonstrated ability to work independently and in a team environment
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Medical Device Senior Regulatory Affairs Specialist KATALYST HLS

Job Description: Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products. Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products. Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines. Provide CMC regulatory guidance to project teams and Global Regulatory team.
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Regulatory CMC specialist KATALYST HLS

Job Duties: • Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications. Qualifications • Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers • At least a Bachelor Degree required. Master's Degree or PhD preferred
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Senior Lead Data Manager KATALYST HLS

Job description: Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities. Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management. Position Summary: The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.
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Statistician II KATALYST HLS

Primary Job Function: Provide appropriate statistical input into study design and analysis of data. Ensures accuracy of programs and documents. Participates in statistical or process related presentations to customers. Core Job Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. Developing Statistical Plan: Effectively communicates with project manager/CRA to understand to objectives of the study. Follows the appropriate operating procedure required for developing the statistical plan. Demonstrates the ability to research and provide appropriate statistical input to the study design. Using templates or examples, writes accurate statistical plans that are clear and understandable to the reviewers. Explains the rationale of the statistical methods to the project team. Study Preparation: Meets with CRA, R&D, Instrumentation scientists, department data collection programmers, and data entry to find the best way of capturing the dat
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Clinical System Designer Katalyst HLS

Job Description: Clinical Database Programmer with extensive data management experience in designing Oracle & Medidata Rave Clinical databases, creating Oracle Clinical validations, derivations and SAS views and 2 years of experience in Clinical Data Management as a Clinical Data Manager/ Analyst with expertise in designing Data specifications document, Edit Check Specifications, User acceptance Testing, External data Specifications, Data transfer specifications Recognized for improving data review efficiency through proficient use of SQL and PL/SQL. Has extensive understanding of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer system. Overall knowledge on Discrepancy Management and communicating with team including External data reconciliation, SAE data checking. Ensures clinical data within EDC is in quality to freeze and lock as appropriate for interim and statistical review Experience with team
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Clinical Regulatory Affairs Associate Katalyst HLS

Description: This position interacts with multiple departments, as appropriate, involved in regulatory submissions. The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission. Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA. Request missing and/or illegible pages, arrange for translations as needed. Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.
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Clinical Trial Manager Katalyst HLS

Required Skills: Manage the operational aspects of clinical trials Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate Prepare metrics and updates for management, as assigned Proactively identify potential study issues/risks and recommends/implements solutions Participate in and facilitate CRO/vendor selection process for outsourced activities Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files) May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines) Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (G
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Senior Quality / Regulatory Specialist Katalyst HLS

candidate who has strong experience in In-vitro Diagnostic (IVD) domain. Candidate should have min of 6-8 yrs of experience and at least 5 yrs of experience in IVD domain Should be knowledgeable on new EU regulations for IVDR
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Clinical SAS Programmer Katalyst HLS

Job Description: With the implementation of NASCO and the EDR, those programs will need to be modified (some field names are different, some data values are different from PMHS to NASCO, some data doesn't exist,some new data exists, etc.) The Actuarial folks currently use a number of views specific to them to collect their data and the SAS programs use those views It has been agreed that the SAS programs will not go directly against the EDR and that new views will be created for Actuarial. The effort to develop the business requirements and build these new views is just starting and will be lead by Actuarial (using EDR and the BI teams as needed) Modifying the SAS jobs cannot start until the views are created and also EDR has completed their work so that we have Member, Benefit, and Claims data available.
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Clinical Data Management Programmer Katalyst HLS

Job Description: The Data Management Programmer I/II will perform data management programming for clinical trials as well as extramural partner trials. The Data Management Programmer I/II will support all platforms and integrations, and will primarily manage electronic data collection and access, all in accordance with GCP and SOPs. BS/MS and/or 8+ years of relevant industry experience. 3+ years of relevant experience in clinical data management and data management programming, oncology trial experience preferred; expertise in the acquisition and management of data from multiple sources
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Quality Engineer katalust HLS

DESCRIPTION: This position is to support business reorganization project as the key quality contact. This position is responsible for ensuring that the project maintains compliance and documents all activities as required by applicable FDA cGMP regulations as well as procedures and standards. The employee must be able to partner internally within quality organization to drive all quality priorities with the project team. This employee must be able to self-manage and work effectively with internal parties, manufacturing sites, and corporate personnel with minimal direct oversight. Oversee Quality and GMP related aspects of the project and qualification activities.
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Project Manager (Regulatory affairs, Medical devices) katalyst HLS

Primary Responsibilities and Duties: Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning, such as any required documentation, sample types and quantities needed, expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy. Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database. Monitor progress of upcoming and ongoing projects. Provide customers, and internal management with progress reports and/or status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.
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Senior Associate II, Records Methodology and Guidance katalyst HLS

Job Description: Reporting to the Director, Records Methodology & Guidance and TMF, the Senior Associate II, Records Methodology and Guidance provides compliance and quality assurance support to all Biogen Global Development departments regarding the management of Global Development records throughout their lifecycle. Additionally, the Senior Associate II works with the Senior Manager, Records Methodology & Guidance to support Global Development colleagues to develop, execute and measure records-related programs and internal controls to ensure that operations are conducted in compliance with applicable records management standards, and to ensure that Global Development and its personnel consistently adhere to the highest ethical standards and comply with applicable legal and regulatory records management requirements. He or she will support the communication and education of staff on records policies and governance. The Senior Associate II will be a part of the organization's record
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Senior Data Manager katalyst HLS

Responsibilities: Execute all DM start-up and data back lock activities, including the development and maintenance of CRFs/eCRFs Edit check and custom listing specifications Data Management Plan CRF Completion Guidelines Conduct user acceptance testing of data outputs per DM specifications Organize and actively participate in CRF review meetings with the client Perform comprehensive hands-on data review of all patient data through query management and/or manual review in accordance with SOPs and Work Instructions. Analyzes study data metrics to continually assess both data quality and study progress Track and provide project status updates to project managers for monthly project team meetings Coordinate with Quality Assurance team to resolve any QA data issues
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Project Manager katalyst HLS

Description: The project manager will be part of the Access Services Project Management Office (PMO). The project manager is responsible for the effective management of cross functional project teams and the efficient governance of the project. This includes planning, executing, milestone tracking, monitoring variances to plan and budget, reporting progress to stakeholders and ultimately ensuring all project milestones and objectives are successfully met. The Project Manager is also responsible for utilizing resources in an efficient manner and maintaining a co-operative, motivated and successful team.
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LIMS Program Manager job - Katalyst HealthCares & Life Sciences - Summit, NJ

March 2, 2018 - LIMS Program Manager - p b Summary: /b /p ul li The Program Manager role will be aligned with the GPDO, supporting the Portfolio Manager and the Business Partner(s) of
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Validation Lead job - Katalyst HealthCares & Life Sciences - Cambridge, MA

March 2, 2018 - Validation Lead - p b Job Description: /b /p ul li Must have hands-on experience in Validation in GMP environment. /li li Experience in Life Science R&D space is
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Regulatory Affairs Manager job - Katalyst HealthCares & Life Sciences - San Francisco, CA

March 2, 2018 - Regulatory Affairs Manager - p b Job Description /b b : /b /p ul li Provides tactical and strategic regulatory leadership to the organization and oversees regulatory
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Manufacturing Engineer,Medical Devices job - Katalyst HealthCares & Life Sciences - Raleigh, NC

March 2, 2018 - Manufacturing Engineer,Medical Devices - p b Job description: /b /p ul li This position is responsible for supporting process and system improvements in a high volume medical device
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Regulatory Manager Specialist job - Katalyst HealthCares & Life Sciences - Bridgewater, NJ

March 2, 2018 - Regulatory Manager Specialist - p b Job Description: /b /p ul li Responsible for writing drug regulatory submissions/licenses including New Drug Application (NDA), ANDA's,
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Clinical SAS Programmer job - Katalyst HealthCares & Life Sciences - Philadelphia, PA

March 2, 2018 - Clinical SAS Programmer - p b Overview: /b /p ul li The consultant will have an opportunity to work on all phases of clinical trial study from I-IV, but mainly phase
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