Senior Project Manager, PA – Katalyst HLS

Monitor the project closely throughout the engagement with the customer and keeps a close contact with customer. The individuals in this position will accomplish project objectives by planning and evaluating project activities and ensure operational objectives by contributing information and recommendations to strategic plans and reviews.


Biostatistical Programmer, Remote – Katalyst HLS

Program mapped and analysis datasets per CDISC standards, tables, listings, and figures and other programming activities in a timely manner.

Biostatistician Katalyst HLS

Job Responsibilities:
Represent Statistics function in support of internal clients and customers.
Author and provide input on relevant sections of clinical research and analytical protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).
Manage data release and review meetings for studies; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for studies.
May be accountable for three or more concurrent clinical studies.

Validation Engineer Katalayst HLS

Job Responsibilities:
Define and lead on-time completion of Design Control Deliverables
Provide subject matter expertise and ownership for Risk Management activities
Identify and drive opportunities to improve the quality system
Accountable for Design Verification and Validation planning & execution

Clinical Trial Manager Katalyst HLS

Job Description:
This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of clients products.
Trial Mgmt, pre-approval inspectation readiness experience required.

Manufacturing Associate I Katalyst HLS

Job Description:
Summary the Manufacturing Associate I is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply.
The Manufacturing Associate I is expected to fully participate in both departmental projects and any quality working teams that may be applicable.
This position shall be responsible for the hands-on execution of activities as they relate to the manufacturing of products.
All of the specific requirements presented in this job description are applicable to the functional area in which it resides.