PK Coordinator

Covance Inc Located in: Madison,  Wisconsin
(Private and Secure - Guaranteed!)

Covance Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

 

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

 

We have a job opening for a PK Coordinator at our Madison, WI  and Leeds, UK locations!

 

The PK Coordinator will liaise with the relevant bioanalytical departments over the transfer of clinical PK and PD data.

 

Responsibilities associated with this position:

  • Maintains own schedules for CDARO PK and stand-alone PK studies
  • Creates and maintains PK Analysis Plan (PKAP) under the supervision of the study pharmacokineticist (Pkist) and/or group manager
  • Conducts non-compartmental (NCA) PK analysis in accordance with the protocol, protocol amendments and/or PKAP under guidance from the study Pkist or group manager
  • Prepares PK analysis methodology sections and compiles stand-alone PK report tables and figures under guidance from study Pkist or group manager
  • Conducts non-compartmental analysis on clinical datasets for use in interim PK reports under guidance from the study Pkist or group manager
  • Draft interim clinical PK reports, including Tables, Figures and Listings
  • Performs QC checking of analysis datasets and/or reports (text, tables and figures) for CDARO and stand-alone PK studies to ensure accuracy and completeness
  • Reviews QA/QC report audits and Sponsor comments for CDARO and stand-alone PK reports with the study Pkist
  • Responds to and incorporates QA/QC findings and Sponsor comments into the final reports under guidance from study Pkist or group manager
  • Proactively communicates and interacts with study team, other departments, and clients
  • Assists study Pkist in communication and interaction with other departments and clients, as applicable
  • Participates in process improvement projects to increase the efficiency of daily/routine procedures and reporting methods
  • Archives clinical PK data in a timely manner
  • Any other duties as assigned by the group manager or Associate Director

 

Covance believes that their best-in-class employees deserve first-class benefits. Covance offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short and long-term disability, and life insurance.

 

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

  • Bachelor degree in a scientific discipline
  • Experience may be substituted for education
  • Ability to learn/utilize PK software (Phoenix WinNonlin), word processing software, database, spreadsheet, and other specialized software like SigmaPlot
  • At least one year of general experience in relevant scientific or clinical fields
  • Excellent communication and interpersonal skills
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CRITICAL REQUIREMENTS

COMPANY INFORMATION

Covance Inc. is proud to be the only drug development company with a full range of research and development services—from lead optimization, to commercialization and life cycle management. Covance, headquartered in Princeton, NJ, is the drug development business of LabCorp with global operations in more than 30 countries.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
 
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: