Senior Manager, Clinical Operations

Clinical Operations and Clinical Study Project Management
* Lead operations activities in the preparation and coordination of clinical trial set-up, maintenance and closure in accordance with GCP and current SOPs.
* Provide study management by interfacing with representatives from key functional groups including Statistics, Regulatory, Marketing and Manufacturing.
* Actively support other functional groups with clinical trial set-up, maintenance and closure (e.g. data management, statistics, medical writing, clinical trial material vendors, etc.)
* Provide expertise and direction on the activities involved with planning, conducting and reporting of clinical data.
* Lead trial initiation activities including protocol development, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
* Ensure overall study progress including development and maintenance of timelines, risk mitigation and contingency plans for all aspects of trial conduct, and management of study scope and change control.
* Actively engage in study oversight to monitor adherence to GCP with timely and appropriate escalation of issues as necessary.
* Participate in the development and review of regulatory documents as appropriate.

Vendor Management
* Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
* Complete vendor proposal requests as required and actively participating in the review and selection process of clinical vendors.
* Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
* Serve as key liaison with project and site management clinical research organizations (CROs) and monitor adherence to contracts and budgets.
* Participate in quarterly trial budget reviews and invoice reconciliation.

Quality and Process Improvement
* Participate in development and review of clinical SOPs.
* Maintain 100% compliance with SOP training.
* Conduct audits and inspection readiness visits to investigator sites and vendors
* Promote and lead process improvement initiatives consistent with GCP operations and project management tools and concepts.

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