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Associate clinical trial manager

This is a Full-time position in San Mateo, CA posted December 17, 2019.

A fantastic opportunity has become available within this growing, globally established biopharma based in San Mateo who continue to make strides in the Oncology and Hematology space.

Having recently signed a $1 bil partnership agreement they are expanding rapidly – looking to add 1 Associate Clinical Study Manager to push forward their Phase I-IIa compounds globally.

Job Description: Leads some aspects of assigned clinical trial(s) and demonstrates a good level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities Works closely with the Study Manager under the guidance and direction of the Clinical Program Lead.

Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters.

Works to ensure adherence to a standardized approach to clinical trial management Reviews, tracks and files study specific documents as well as create and update study specific reports Exercises discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks Strong organizational skills are required, as well as the ability to balance changing priorities Acts as a regional lead for large global studies, works under the guidance of the Study Manager Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc.

Coordinates and tracks the distribution and retrieval of documents.

Assist in the set up and perform oversight of the electronic Trial Master File according to ICH-GCP, and company SOPs Ensures all documentation is in a state of audit readiness.

Prepares study related documents, i.e.

clinical trial tools, trackers & templates etc.

Coordinates with Supply Operations regarding drug forecasting and supply of study drug/comparator drug to sites Performs oversight of Central Lab and other ancillary vendors during start-up, conduct, and close-out.

Assists with vendor management during the coordination of Investigator Meetings.

Creates agendas and minutes during study team meetings under the direction of the Study Manager.

Performs some administrative tasks to support Clinical Operations Department and team members as needed Demonstrates knowledge of sample collection, analysis process and sample reconciliation.

Contributes to and reviews changes in scope and change orders Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations