Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
Ardea is searching for a Sr. Clinical Trial Mateiral Associate to join the team.
The Senior Clinical Trial Material Associate will manage Clinical Trial Material (CTM) projects including cGMP document review, clinical study drug management and other general activities including but not limited to duties in the following functional areas; study drug shipment planning, shipment and tracking, inventory management, retest update tracking, drug reconciliation, billing/invoice support and assisting with the maintenance of the company Electronic Document Management System (EDMS) as well as the drug supply IXRS as it pertains to CTM delivery and documentation. For projects assigned, Sr. CTM Associate shall be responsible to manage drug supply chain activities as directed by the lead of Pharmaceutical Sciences for that project and in accordance with Ardea SOPs, Regulatory regulations/guidelines and project requirements. The Sr. CTM Associate is given increased responsibilities to lead specific activities and can resolve issues, make decisions, and escalate issues appropriately.
Primary Duties and Responsibilities
Function as a leader in the creation, maintenance and coordination of full drug reconciliation process including review and approval of drug reconciliation records across clinical studies working directly with functional representatives (Clinical, Quality Assurance, etc.) as needed.
Assist in the technical review of clinical trial material documents; manage logging and archiving of CTM packaging records into document tracking system, First Point and any Quality Assurance (QA) systems as appropriate.
Track drug supply and maintain current inventory records for clinical trial material.
Track retest updating of clinical trial material.
Develop templates and SOPs that assist in the management of CTM processes.
Assist with special projects as needed.
BioSpace.com - 16 months ago