March is National Kidney Month – Katalyst HLS

March is National Kidney Month

|| Awareness || Prevention || Treatment ||

Katalyst HealthCares & Life Sciences

Kidney_Month_Katalyst HLS

FDA World Health Organization

U.S. Department of Health and Human Services (HHS)


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

Clinical Regulatory Affairs Associate Katalyst HLS

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.

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

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

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.

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