Senior Director, Clinical Operations

Job Category: Biotech/R&D/Science Career Level: Manager (Manager/Supervisor of Staff) The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider.  We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  We are seeking a Senior Director, Clinical Operations, Southeast Region to join the team. PurposeDirect clinical monitoring operations for a group of offices, a designated region or a defined functional accountability within aregion. Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area ofaccountability. Determine strategic goals and objectives for designated region and assures operational alignment with seniormanagement priorities. Lead regional or functional strategic initiatives and work with senior management across disciplines todevelop implementation plans. Responsibilities• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning,assigning, and directing work; appraising performance and guiding professional development; rewarding and discipliningemployees; addressing employee relations issues and resolving problems. Approve actions on human resourcesmatters.• Direct the hiring and selection process for a region/country or office and works collaboratively with senior management toset targets for recruitment and retention across roles.• Establish methods to develop and evaluate office/region based onboarding processes. Develop standard processes toensure that staff have the proper materials, systems access and training to complete job responsibilities. Oversee theexecution of the training plan, SOP review and mentored training experiences for a region/office/country.• Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and futureresource alternatives, pro-active planning and collaboration with study team leadership and operational peers.• Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function. Evaluateregional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with seniormanagement and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinicalprojects.• Act as a coach and mentor for line managers, Clinical Study Managers (CSMs) and Clinical Study Director (CSDs) asthey develop in their role. Work collaboratively with project leadership including the PM, client representatives and otherfunctional leadership to manage project related challenges and to achieve exemplary customer service.• Analyze and reviews budgets for clinical studies within region. Pro-actively plans for appropriate clinical operationsbudget consumption and guides line managers and CTLs in managing variances and in developing corrective fiscalaction plans.• Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines andinterfaces with appropriate functional leadership to achieve positive outcomes.• Lead corporate or departmental quality or process improvement initiatives. Act as a client liaison Bachelor's degree in a health care or other scientific discipline or educational equivalent; 12 yrs of experience working on clinical trials with 9 years experience in a leadership capacity; or equivalent combination of education, training and experience.  In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Knowledge of clinical research financial parameters and project financial tracking and accounting methods. Strong leadership skills. Effective presentation skills. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Strong written and verbal communication skills including good command of English. Excellent organizational and problem solving skills. Effective time management skills and ability to manage competing priorities. Ability to establish and maintain effective working relationships with coworkers, managers and clients.