Principal Scientist, Clinical Operations

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, Clinical Operations to be in Spring House, PA.

Purpose:

This is a clinical operations support position within the Bioanalytical Discovery and Development Sciences (BDDS).

We work with internal bioanalytical groups and external partners to ensure the completion of all activities related to clinical study data deliveries and sample management.

We work to support all therapeutic areas within Johnson & Johnson, spanning nonclinical studies to post-market clinical development.

You will be responsible for:


* Serve as a point of contact within the Trial & Laboratory Operations group, serving as primary liaison to partnering groups, as well as a representative on project teams as required.


* Ensure accurate receipt, shipment, handling and storage of frozen biological specimen samples in support of non-clinical and clinical studies.


* Lead a team to support all aspects of the receipt and inventory of frozen laboratory samples sent from central laboratory or contract laboratory into freezers using Laboratory Information Management Systems (LIMS) to track sample chain of custody.


* Ensure samples are provided to scientists for analysis using LIMS to meet study timelines.


* Support management of the sample storage assets (freezers, chart recorders, handheld scanners, etc.), as well as the freezer inventory system and other sample management activities with contractors.


* Review and provide comments on the technical documents (protocols, statement of works and lab manuals) from internal groups, Central Laboratories, and outsourced bioanalytical laboratories for studies where the department conducts analyses, receives results, or has oversight of an ex...