Clinical Trial Manager
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POST DATE 9/16/2016
END DATE 10/17/2016
JOB DESCRIPTIONThe Clinical Trial Manager (CTM) provides comprehensive oversight of clinical trials for Aduro Biotech, Inc. The position requires an individual with clinical trial management experience, who has strong, professional written and verbal communication skills, good organization, attention to detail, and the ability to consistently provide high quality work while prioritizing tasks and meeting timelines. The ideal candidate thrives in a fast-paced, team-oriented environment and is adaptable to rapidly changing priorities. This position is a contract to perm hire.
Manages all operational activities pertaining to the execution of late phase clinical trials, including day-to-day interactions with CROs, vendors, consultants and clinical sites as necessary
Provides leadership to the clinical study team to ensure efficient and effective trial conduct
In conjunction with Management, develops study timelines and budgets
Maintains systems for tracking study progress in order to provide timely updates to Management; monitors study progress to ensure adherence to timelines and continued compliance to SOPs and applicable regulations
Identifies tasks required for successful study execution and directs team members (including CROs and vendors) to effectively accomplish objectives
Coordinates the development of study documents including Study Reference Manuals, Pharmacy Binders and CRFs
Prepares, collects and tracks required regulatory documentation from clinical sites
Manages the monitoring of clinical studies, including development of monitoring plans and supervision of site monitors and site communications; may include some site monitoring and/or co-monitoring
Reviews monitoring reports, tracks study invoices (sites and vendors) and maintains study files
Coordinates the evaluation and selection of new investigators and vendors such as central laboratory services and CROs
Directs the planning of site initiation visits, Investigator Meetings and other study meetings (e.g., Data Monitoring Committee)
Works with Medical Monitor to manage critical safety issues
Manages high-level study issues that require cross-functional and/or Management input
Coordinates development of database specifications, edit specifications and Case Report Forms for electronic data capture (EDC) or paper-based data management systems
Projects, orders and tracks clinical investigational drug and non-drug study supplies
May manage CRAs and contract research staff, including providing mentoring opportunities and development plans for direct reports
Contributes to development and maintenance of Clinical department operations