The Senior Manager, Clinical Supply manages clinical supply chain of compounds in the clinical stage of development.
Essential Functions of the Job (Key responsibilities)
Manage all aspects of clinical study requirements and Clinical Packaging activities.
Work with clinical operations, project management and tech ops to establish and meet timelines for clinical supplies available for clinical trials.
Identify external packaging sites, monitors external clinical packaging, and reviews master and executed batch records.
Coordinate GMP auditing activities at CMOs; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements.
Work with tech ops and clinical operations in managing inventory of clinical supplies before and during clinical studies.
Develop and manage strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS or higher and minimum 5 years of experience in managing clinical packaging, clinical inventory and distribution.
Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Learn more at:
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
