- Duties and Responsibilities:
-Designs and reviews protocols, prepares reports, and carries out kinetic analysis of mostly pre-clinical toxicokinetic/pharmacokinetic studies -Conduct kinetic analysis using noncompartmental approach.
-Review analysis plans with clients to determine their needs and to suggest/guide plans to accomplish these needs.
-Participates in appropriate client visits.
-Provides guidance and leadership to ensure project completion.
-Reviews technical validity of projects and test results.
-Evaluates experimental data and writes scientific reports.
-Assists in development of departmental policies, procedures, and training manuals.
-Trains and mentors pharmacokinetic study coordinators.
-Assists in the development of new report formats as needed and improves processes to increase the efficiency of daily/routine procedures and reporting methods.
-Reviews study status against initial work plan.
-Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
-Reviews QAU report audits and submits audit responses for SD/management approval.
-Reviews client comments and ensures that all necessary report clarifications are completed.
-Oversees report productions through finalization, including archival of data.
-Maintains positive control over timing and scheduling issues related to every aspect of the study process.
-Co-authors scientific papers/posters which are published or presented at scientific meetings.
-Assures on-time delivery of high quality data and reports.
-Assures that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.
-Provides relevant information to assure accuracy of forecast and revenue recognition.
-Performs other related duties as assigned.
- Bachelor’s or Master's degree in science.
- 2-3 years experience in pharmacokinetic data analysis and report writing. Including 3-4 years experience in prior study/project management related role.
- Relevant experience may be substituted for education.
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