Associate Director, Clinical Operations (Office Based) - NCR
Novella Clinical Resourcing is Seeking an Associate Director, Clinical Operations:
Serve as a leadership resource in the day-to-day operations. Oversee project management for all projects through direct supervisionand mentoring of assigned project leaders to ensure that contracted servicesare performed on schedule, within budget, in compliance with applicableregulatory requirements, and in accordance with sponsor specifications.Facilitate problem-resolution and issue escalation across all projects.Support business development efforts through participation in sponsor meetingsand the preparation of proposals, budgets, and payment schedules for new projectsin conjunction with assigned proposal project leaders. Monitor the financialperformance of all projects. Serve a primary role as operations resource forthe Faculty Leader and for BusinessDevelopment. Provide team leadership for the Core Team and facilitate thedevelopment of tools and resources needed for clinical research projects.Serve as a project leader for clinical research projects as assigned by theDirector of Project Leadership. Perform administrative duties required fordirect supervision of project leaders conducting clinical research projects.
Work with functional groups and IDproject leaders to identify key operational needs and opportunities forimprovement in the conduct of ID clinical research. Assist in the developmentof appropriate operational tools, resources and capabilities that fosterconsistency, efficiency, and strong relationships between internal partners.
Work with the Faculty Leader, Faculty, and SiteManagement personnel to identify and recruit an adequate number of qualifiedinvestigative sites and to develop strategies to educate sites and generateenthusiasm and interest in clinical research projects. Work with personnelto ensure that key data elements are captured in the investigator database forsites participating in trials and that metrics are used to improve siteselection and performance.
Serve as the senior Project Leadership representative for clinical researchprojects. This includes supervising and mentoring project leaders conducting projects to develop and implement operational plans while ensuring thatprojects are completed in accordance with the applicable regulatoryrequirements as well as the established budget, timelines, and sponsorspecifications. Ensure appropriate use of project management tools. Serve as aresource to project leaders in troubleshooting project-related issues.
Provide reports to the ID Therapeutic Area Faculty Leader and to the Directorof Project Leadership regarding the status of all ID clinical researchprojects.
Serve as a leadership resource for Faculty and personnel regarding theoperational aspects of clinical research. Provide training for projectleaders involved in the conduct of research. Work with functional groups andHuman Resources to develop training programs regarding key clinical topics forpersonnel conducting clinical research projects.
Review information from audit reports and post-project debriefing sessions(i.e., lessons learned for completed projects) to identify opportunities toimprove the conduct of clinical research projects. Coordinate thecommunication of recommendations to the Faculty Leader, Faculty, the Director of Project Leadership, the Core Team, and to projectleaders and functional groups.
Work with Core Team members to develop a library of standard CRF modules toensure consistency in data definitions across all projects and facilitatethe aggregation and analysis of data sets from different projects.
Provide direct supervision for project leaders assigned to clinical researchprojects. Responsibilities include, but are not limited to, facilitation ofinternal partnering, orientation and training, performance evaluations, careerdevelopment plans, work assignments, vacation schedules, and serving as amentor.
Make recommendations to the Director of Project Leadership regardingpromotional decisions for Project Leaders.
Assist the Director of Project Leadership and the FacultyLeader in identifying and recruiting project leaders involved in the conduct of clinical research projects.
Work with the Faculty Leader, Finance personnel andfunctional group leaders to monitor project expenditures, identify potentialefficiencies, and develop strategies to optimize the profitability of clinical research projects.
Work with Project Leaders conducting projects and with Finance personnel toprovide reports to the Faculty Leader and administrationregarding the financial performance of individual projects.
Business Development and Marketing
Support business development efforts by serving as a primary operationalrepresentative of the Therapeutic Area, maintaining liaison with theBusiness/Therapeutic development representatives and responding to inquiriesregarding operational activities.
Work with the Faculty Leader and Business/TherapeuticDevelopment to set priorities regarding the timing of new projects and toprovide input in the development and implementation of marketing plans(including the design and production of promotional materials and standardslide presentations).
Provides direction and input in the development of operational plans for newproject proposals including the services they will provide, as well aspotential collaborations and outsourcing.
Represents the operational capabilities of the Therapeutic Area and the discussions with sponsors regarding potential clinical research projects.
Provides input to functional groups regarding staffing and resource needs forpotential and newly awarded clinical research projects.
Performs other related duties incidental to the work described herein.
Bachelor of Science degree in a medical/life sciences field. Strongly prefer ahealth care professional (RN, PA, RPh, MT, etc.) Strongly prefer candidateswith a Master’s Degree or other post-graduate training in a clinical disciplineor business/health care administration (MSN, PharmD, PhD, MBA, MHA, MPH).
Previous experience as a senior level project leader (with a minimum of 6 yearsof project management experience) in an academic research organization,contract research organization, or pharmaceutical, biotechnology, or medicaldevice company. Previous supervisory experience is required.
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