Study Director

Study human society and social behavior by examining the groups and social institutions that people form, as well as various social, religious, political, and business organizations. May study the behavior and interaction of groups, trace their origin and growth, and analyze the influence of group activities on individual members.

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Study Director Job Description Template

Our company is looking for a Study Director to join our team.

Responsibilities:

  • Design, coordinate and implement study plans and final reports;
  • To review and optimise Analytical Laboratory Methods and Standard Operating Procedures;
  • Report to sponsors/clients with updates on the study plan;
  • To manage immunoassay studies, including PK, ADA and biomarker investigations, and ensure project delivery in a timely manor;
  • Oversee processes and personnel to ensure project completion and adherence to GLP requirements;
  • Summarising Final Report with detailed scientific findings, data analysis & conclusions;
  • Coordinate with Quality Assurance teams for auditing and Final Report;
  • Ensure stock levels for study execution;
  • To ensure data integrity and regulatory compliance relating to Good Laboratory Practices;
  • To liaise effectively with internal and external stakeholders;
  • Project management from initial concept through all development stages to project completion and post completion technical support;
  • Assisting in developing GMP capability and ensuring all activities meet GLP requirements;
  • Conducting and developing high quality services using human tissue and stem cells;
  • It will be your responsibility to ensure studies are conducted in accordance with approved study plans and in compliance to GLP principals;
  • You will be involved with high quality preclinical toxicology studies where you will be ensuring the team meet study deadlines.

Requirements:

  • Experience of driving the introduction of new instruments, processes and best in class practices;
  • Strong background in the development of LC-MS bioanalysis methods in support of PK and Biomarkers;
  • Experience in a client facing role with the ability to provide high level advice and guidance to clients;
  • Strong background in support of regulatory validation and sample analysis studies;
  • A minimum of 2 years’ appropriate experience in clinical and/or preclinical bioanalysis laboratory;
  • Experience in a regulatory environment and in directing regulated studies, experience working with GLP and GCP.