Clinical Data Manager - Boston, MA - Katalyst HLS.com

Serve as the client DM team member on the client study team and as the sponsor DM representative on the client-CRO study team. Provide direct oversight to the CRO during study start-up, maintenance, and lock ensuring the protocol is being followed. Review of external vendor data including biomarker data. Review of Medidata Rave eDC generated data.

https://www.indeed.com/job/clinical-data-manager-e57beb6bba855ac9

Senior Statistical Programmer - Boston, MA - Katalyst HLS.com

To support the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.

https://www.indeed.com/job/senior-statistical-programmer-313e2bda74a60f56

Quality Engineer - Berkeley, CA - Katalyst HLS.com

The Operations / Quality Engineer is responsible for supporting existing product lines to ensure safety, compliance and product availability. In addition, provide engineering support to manufacturing for transition of new products and scale-up for production.

https://www.indeed.com/job/quality-engineer-22bb4aaf17837dcb

Regulatory Consultant - East Hanover, NJ - Katalyst HLS.com

Regulatory consultant works under minimal supervision to support the development of digital and other innovative technologies, as stand alone or in combination with Client products. This role supports Global Program Regulatory Directors (GPRDs) and Digital Development teams in operationally implementing the global regulatory strategy for the development of Client technologies and approaches to clinical development, applying expertise in drug development and medical device regulations.

https://www.indeed.com/job/regulatory-consultant-60cf979ee9614683

Regulatory Submission Publisher - Princeton, NJ -KatalystHLS.com

Roles and Responsibilities: Responsible for both Submission and Document Level Publishing. Responsible for the creation, assembly, and publishing of global electronic submissions, including MAAs/NDAs, INDs, CTAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc. Knowledge of health authority procedures/guidance\'s regarding electronic submissions required. May interface with project managers, regulatory product managers, and or content authors to discuss submission preparation.

https://www.indeed.com/job/regulatory-submission-publisher-53c207c5aebebbf3

Principal SAS Programmer - Rumford, RI - katalysthls.com

Roles and Responsibilities: Convert study design and specifications into programs to support clinical trials. Validate SAS programs written by others. Assists Management in maintaining SOPs and work instructions relevant to SAS programming. Follow regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.

https://www.indeed.com/job/principal-sas-programmer-b7c53af9174fe76f

Computer System Validation Lead - San Diego, CA

Computer System Validation Lead - San Diego, CA

https://www.indeed.com/job/computer-system-validation-lead-dfe5039f442c70fc