Study Director I - Metabolism

Labcorp•Greenfield, IN

6d•Onsite

About The Position

Labcorp is seeking a Study Director I – Metabolism to join our team in Greenfield, IN! The Study Director I is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements in a fast-paced environment. The Study Director is the single point of study control and has overall responsibility for the scientific, technical, and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.

Requirements

Bachelor of science degree with 5 or more years of experience in research or Master of science degree with 2 or more years of experience in research
Awareness of requirements for working within a GLP, GCP and GMP (as appropriate) environment
Basic awareness of the drug development process, regulatory requirements and the scientific techniques of standard metabolism studies required
Strong client relationship building and management skills
Ability to communicate effectively verbally and in writing
Strong attention to detail, organization, and time management skills
Skilled in performing scientific presentations and preparing scientific publications
Experience in a feeder role for a study director with skills and competencies in the relevant study types
Previous data interpretation and report writing experience
Working knowledge of MS Word, Excel, PowerPoint and general IT skills

Nice To Haves

PhD degree
2 or more years of experience with In vivo Pharmacokinetics (PK)

Responsibilities

Coordinate efforts of the study team.
Learn to develop protocols and ensure that the protocol, including any changes, is approved and in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
Ensure that test and control articles are available, have been tested for identity, etc., and that appropriate technical data are obtained. Also ensure that handling precautions are sufficient to ensure operator’s safety and that this information is given to the operational areas.
Learn to review cost estimates to ensure that all protocol/amendment driven work scope specifications are included in the price estimation.
Understand financial status of ongoing studies.
Monitor progress and status of assigned studies. Ensure that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
Direct preparation of reports, ensure compliance with protocol and regulatory requirements, and submit them to the client.
Participate in and may host client visits.