Director, Clinical Operations (440087)

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POST DATE 9/15/2016
END DATE 10/14/2016

Advanced Clinical South San Francisco, CA

South San Francisco, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Job Description:

OVERVIEW:The Director, Clinical Operations develops and implements strategic direction in the conduct of multiple clinical studies. Accountabilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors. Oncology experience is required. The Director contributes Clinical Operations expertise in cross-functional meetings and initiatives. Management and mentoring of junior Clinical Operations staff is expected. ESSENTIAL DUTIES AND RESPONSIBILITIES: Accountable for overall management of multiple clincial trials including: - Providing strategic direction to study teams to meet corporate study goals and timelines; - Oversight of vendor budgets and contracts, in conjunction with Development Outsourcing - Reporting and justification of study metrics to executive management, as requestedContributes expertise, ensures consistency, and captures efficiencies in all operational activities pertaining to the execution of clinical trialsPartners with and maintains regular contact with Client s relevant departments such as Regulatory Affairs (RA), Biostatistics and Clinical Data Management (BCDM), and others as necessaryParticipates in the selection of Contract Research Organizations (CROs) for both large budget ( $20 million) and small budget (