Clinical Trial Manager

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POST DATE 9/15/2016
END DATE 11/2/2016

Raptor Pharmaceuticals Novato, CA

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


div class="col-sm-12 col-md-8 col-md-offset-1 col-md-push-3" strong Clinical Trial Manager /strong p span span span strong Location:  Brisbane, CA /strong /span /span /span /p p span span span strong Requisition #: 58-3200-2016R /strong /span /span /span /p p strong span span span Summary Description /span /span /span /strong /p p The Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring GCP Compliance, high study quality and timely completion. This position is responsible for assisting in meeting functional, organizational and corporate goals for this new product by providing successful management of clinical study teams and clinical trials. /p p span span span strong Responsibilities /strong /span /span /span /p ul style="list-style-type:disc" li Leads the Clinical Study Team for assigned projects.  May lead one or more clinical studies, from concept to protocol, and through the achievement of corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc. /li li Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates and Clinical Trial Assistants /li li Prepare / Review / Approve study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual /li li Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents /li li Assist with protocol development and study report completion /li li Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols /li li Provide guidance, direction, and management to CRAs /li li Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities /li li Coordinate study supplies /li li Negotiate and manage contracts /li li Review Informed Consent Forms, CRFs, and study related materials /li li Plan and participate in investigator meetings /li li Assist and support data query process /li li Ensures trial master file is current and maintained /li /ul p span span span