Clinical SAS Programmer - Cambridge, MA - KatalystHLS.com

Clinical SAS Programmer - Cambridge, MA - KatalystHLS.com Looking for quality candidate to support the SAS stats programming for clinical & non-clinical projects/studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project\'s needs.

https://www.indeed.com/job/clinical-sas-programmer-782837259d9920d1

Biostatistician - Beverly Hills, CA - KatalystHLS.com

Biostatistician - Beverly Hills, CA - KatalystHLS.com Work closely with team to ensure deliverables in accordance with ICH-GCP, define relevant Standard Operating Procedures (SOPs) and/or client-specific requirements. Develop, revise and maintain SOPs and provide training on new and revised SOPs as needed. Drive CAPA/remediation as needed for biostatistics activities. Develop and implement training programs for appropriate departmental teams.

https://www.indeed.com/job/biostatistician-a0d69fb39b943489

October 29, 2019 - World Psoriasis Day

October 29, 2019 - World Psoriasis Day Katalyst HealthCares & Life Sciences World Health Organization #WorldPsoriasisDay2019 aims at: Raise awareness; Spread information; Improve access to treatment; Give the psoriasis community a voice #Psoriasis #KatalystHLS #WHO KatalystHLS.com

http://katalysthls.com/

Business Development Manager, Staffing - South Plainfield, NJ 07080 - KatalystHLS.com

Business Development Manager, Staffing - South Plainfield, NJ 07080 - KatalystHLS.com Business Development Manager sells the staffing process/services of Katalyst HLS by obtaining, securing, and sustaining business with professionals within the Pharma/Biotech/Medical Device/CRO industries. Katalyst HLS is specialized in the connecting top employers with the best talent around. Our focus areas include: #ClinicalResearch #ClinicalDataManager #Biostatistician #ClinicalSAS #DrugSafety #Pharmacovigilance #MedicalWriter #RegulatoryAffairs #Manufacturing #QualityAssurance @QualityEngineer #Validations #ValidationEngineer #Staffing #BusinessDevelopmentManager #VMS #MSP

https://www.indeed.com/job/business-development-manager-staffing-dc7e7571df4d69ac

Clinical Data Manager - Boston, MA - KatalystHLS.com

Clinical Data Manager - Boston, MA. KatalystHLS.com Serve as an active member of Study Teams. Work with other functions to manage timelines and ensure that clinical data management deadlines are met. Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables. Work with database builders to develop EDC databases, edit checks and reports. May define database and edit check specifications to support the protocol and analyses

https://www.indeed.com/job/clinical-data-manager-2ea0bf8b5dadc561

Biostatistician - Beverly Hills, CA - Indeed.com

Biostatistician - Beverly Hills, CA - Indeed.com Overview: Our Medical Device client in CA is looking for a Biostatistician who can be on site 40 hours a week to help with their clinical studies. They are a Medical Device client, but the consultant can come from Pharma as Device experience is a plus not a must. The candidate must be a go getter, willing to learn, takes direction and is adaptable to a fast-paced environment. The manager is open to an individual who has 2-7 years\' experience (more is OK, but she said she has struggled in the past with these people as they are not as adaptable to follow the company processes).Roles & Responsibilities: Work closely with team to ensure deliverables in accordance with ICH-GCP, define relevant Standard Operating Procedures (SOPs) and/or client-specific requirements. Develop, revise and maintain SOPs and provide tr

https://www.indeed.com/job/biostatistician-a0d69fb39b943489

Senior Statistical Programmer - Deerfield, IL - Indeed.com

Senior Statistical Programmer - Deerfield, IL - Indeed.com Roles and Responsibilities: Develop programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros. Collaborate with manager and other programmers through participation in formal and ad-hoc meetings. Prepare documentation on all production programming and validation activities; utilize best industry business practices and data standards for clinical data submissions to the FDA and other global regulatory agencies. Assist manager through contributions to continuous improvement by developing standard programs and macros that follow CDISC guidelines required for regulatory submissions. Independently program CDSIC SDTM, ADaM datasets. Map raw data to SDTM (Study data table model) in compliance with CDISC data model standards and create specifications for programming. Create ADaM Specifications & datasets from SDTM datasets per CDISC analysis data model standards an

https://www.indeed.com/job/senior-statistical-programmer-b426b445abad4e8f

Labeling Resource - Salt Lake City, UT

Skills and Experience Required: Medical device experience (senior level, class II preferred) Labeling expertise, including IFU EU MDR and MDD knowledge Design change experience Global Regulatory assessments Excellent written and oral communication IVD experience Remediation experience preferred.

https://www.indeed.com/job/labeling-resource-e0e637825a38328e

Regulatory Affairs Specialist III - Swiftwater, PA - KatalystHLS.com

Primary Duties: program/project management - need to be able to multitask, organized preparing for inspections of drugs in global clinical trials managing CAPAs/audits process integration managing vendors contract to perm can be at Lexington site instead of Cambridge site experience in Track Wise a plus GCP, systems/metrics experience (not GXP - this is an R&D role) Key areas of accountability and budget responsibility, if applicable. Under the direction of the Head of Internal & Supplier Audits, this position is responsible for supporting the overall execution of the overall Internal Suppler & Audit (ISA) strategy and ensure adherence to R&D QA & Compliance (QA&C) Operational objectives.

https://www.indeed.com/job/regulatory-affairs-specialist-iii-09bfc38f993bd3f1

Quality Assurance & Compliance Manager - Cambridge, MA - KatalystHLS.com

Primary Duties: program/project management - need to be able to multitask, organized preparing for inspections of drugs in global clinical trials managing CAPAs/audits process integration managing vendors contract to perm can be at Lexington site instead of Cambridge site experience in Track Wise a plus GCP, systems/metrics experience (not GXP - this is an R&D role)

https://www.indeed.com/job/quality-assurance-compliance-manager-76029a8119b0c765

Senior Clinical Data Manager - New York, NY

The Clinical Data Manager will be responsible for all data management responsibilities for a sponsor-initiated cancer study. This person will be developing CRF\'s, supporting data entry and collecting Adverse events in real time. Train users on EDC functionality. Understand, update and optimize existing queries/reports. Analyze data to find potential issues/inconsistencies/areas, etc.

https://www.indeed.com/job/senior-clinical-data-manager-446b51280676f12d