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Director, Clinical Operations

Company: JGB BioPharma Consulting Inc.
Location: San Diego
Posted on: June 14, 2018

Job Description:

Description: Provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality, and risk mitigation Lead the development of contingency/risk management plans for projects and assist the Sr. Director of Clinical Operations in the preparation and execution of sound development strategies Expected to lead the day-to-day activities of one or more assigned clinical trials; acting as the responsible Clinical Trial Manager Oversee the activities of direct reports on the clinical operations team Collaborate and ensure strong relationships with colleagues, outside consultants, and vendors to ensure successful completion of assigned clinical trials Engage stakeholders in ongoing open dialogue that uncovers and mitigates challenges and leads to strengthening of the clinical team and its success Accountable for quality data, meeting timelines and providing guidance to clinical study team as needed. Oversees the review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures Oversees the review and the approval of the CRO/vendors, vendor on-boarding and management throughout the life-cycle of the study Responsible for hiring, training, mentoring and managing the day-to-day activities of the clinical operations group, including Clinical Trial Managers, Clinical Research Associates and Clinical Trial Assistants Serves as point of contact for day-to-day issues escalation and resolutions on assigned projects, and in support of assigned clinical operations staff Reviews status reports and timelines for milestone deliverables generated by CTM/CRA/CTA (subject tracking reports, biological sample management reports, drug inventory) Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation Actively contributes to clinical operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs, WIs and department level training Conducts ongoing performance management, performance reviews/appraisals and career development planning for all direct reports Responsible for building a sense of esprit de corps within the clinical department Requirements: BA/BS or equivalent degree in scientific discipline (required) 15+ years of clinical trials research management experience in a pharmaceutical/biotechnology company (preferred), CRO industry experience (considered) Minimum 5 years experience in a line management/supervisory role Demonstrates extensive technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing) Excellent attention to detail and accuracy in work with proven ability to work independently, with a high level of integrity on multiple tasks Strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality Excellent sense of urgency to deliver at/surpass study conduct targets Proven experience working in an emerging biotechnology/pharmaceutical/CRO company leveraging outsourced work to CROs/vendors Ability to establish and maintain effective working relationships with coworkers, assigned staff, and senior management Computer skills including proficiency in use of Microsoft Outlook, Word, Excel and PowerPoint Experience with SmartSheet (preferred) Experience with Veeva Vault eTMF system (preferred) Expert knowledge of ICH GCP as relates to clinical trial management Demonstrated financial acumen in planning and managing clinical program budgets Experience at/or oversight of outside clinical research vendors (CROs, central laboratories, imaging vendors, IXRS, etc.) Extensive experience and accomplishments in the pharmaceutical or related industry, e.g., with proven Global Phase 1-3 study experience and with filing INDs, CTAs and BLA/NDAs (highly preferred) Experience in oncology and/or autoimmune therapeutic areas (highly preferred) Must be willing to travel (approx. 5%)

Keywords: JGB BioPharma Consulting Inc., San Diego, Director, Clinical Operations, Executive, San Diego, California

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