Study Director/Senior Scientist

About the role

A Study Director has the overall technical responsibility of a study and functions as the liaison between the laboratory staff and the Project Manager. Responsibilities include supervising and coordinating activities of client projects, identifying areas of improvement and developing new processes, leading and managing the execution of assigned studies.

Responsibilities

• Provide strategic and technical oversight on studies.
• Collaborates on continuous process improvement opportunities.
• Draft study plans and contribute to the preparation of reports for sponsors.
• Function as the Subject Matter Expert (SME) on studies, particularly on sponsor calls.
• Ensure compliance with study protocols and regulatory guidelines.
• Transfer all raw data, documentation, protocols, specimens, and final reports to the archives during or at the close of the study.
• Adhere to MedPharm’s Procedures.
• Contribute to the preparation and review of SOPs and Forms where applicable.
• Promptly record all data according to Good Documentation Practices.
• Review literature in preparation for studies and update knowledge by reviewing appropriate literature.
• Supervisory Responsibilities - This position may be responsible for training, assisting, or assigning tasks to others.

Requirements

• Bachelor’s degree in relevant scientific field (e.g. Chemistry, Biology, etc.)
• 3-5 years of relevant experience
• Proficiency in technical writing
• Ability to analyze data sets and interpret results
• Familiarity with JMP is a plus, but not required
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.)

Qualifications

• The studies that a study director would be leading are pre-clinical in vitro studies conducted at the MedPharm Research & Innovations site.
• Most of the assigned studies would include but are not limited to:
• In Vitro Release Testing (IVRT)
• In Vitro Permeation Testing (IVPT)
• Research Biology (e.g. various biological models, IVPT on various tissue constructs, etc.)
• The majority of the assigned studies will be conducted under R&D with a small percentage conducted under a regulated setting (e.g. in vitro bioequivalence).

Skills

• Technical writing
• Data analysis and interpretation
• Good Documentation Practices
• Microsoft Office proficiency

Benefits

N/A

Pay

N/A

Schedule

N/A