Director, Clinical Operations (APEX CRA)

If you’re looking for a role that combines your clinical operations expertise, exceptional leadership skills, business savviness, and would love an opportunity to join a highly dedicated and tenured leadership team as the Director / Associate Director of Clinical Operations (APEX CRA Program), Parexel has an incredible opportunity for you!

The Accelerated Program of Education, Exposure, and Experience for CRAs(APEX CRA) provides foundational clinical research training - including project and system experience - to new CRA hires who are recent college graduates and have less than a year of monitoring experience. This program is unique and industry leading. This position will have the ability to enhance and expand the program.This role is remote and can be located anywhere in North America25% travel required; primarily to Raleigh, North Carolina

The Director / Associate Director is responsible for:Overseeing a team of high-level individual contributors or a group of Managers; will directly manage 7 Line ManagersDay to day oversight of the APEX CRA Program in the Americas while working with counterparts in Europe to ensure alignmentResourcing client projects with suitably developed professionals and to retain and develop these professionals

Project Delivery Management and OversightMonitor performance by close interaction with project leadership/functional leadership/client and may also be required to ensure that ongoing/revised project documentation and correspondence is accurate and complete.May be responsible for own assignments as project team member. This may include but not limited to taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables, generating study specific status reports for study teams, Sponsors and/or management, and attend project team meetings as required at the project levelProvide expertise and consultation, facilitate metrics collection and develop action plans in conjunction with Director/Project Leader/Lead to keep projects on time and within budgetManage and oversee team and departmental activities includingappropriate resourcing of staff, staff assignments, quality control andefficiency of project deliverables.Produce accurate resourcing plans in conjunction with appropriate Project Team Members, including but not limited to facilitating appropriate resource identification and assignment, and monitoring resource needs throughout the project as neededAct as executive oversight of a large project where applicable

Performance Management, Staff Development and Talent ManagementProvide technical support to team members and managers to ensure that they have the required knowledge to fulfill their dutiesEnsure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan and ensure quality check of department deliverables (e.g., site visits, Central File documentation) and take appropriate remedialMeet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated teamUndertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives. Determine training needs and collaborate with appropriate learning and development organization to ensure availability of appropriate training.Ensure team members improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measuresParticipate in formal staff review processes e.g., performance and salary reviews to corporate standards and timescalesWork with senior departmental management in developing managers and ensuring a talented pipeline of management staff within the department or function

General Operations and Functional/Business Unit ManagementParticipate in, champion or lead Parexel and department system/standards improvement activities or committees, task force groups as needed, including change managementMaintain an agreed level of productivity/billability and staff turnoverComplete routine administrative tasks in a timely manner (e.g., timesheets, training, travel expense claims). Manage compliance with travel and billability guidelines for department, region, or function, where appropriate. Travel as neededEnsure client and business needs are met and that all projects are optimally resourced with experienced staffImplement process improvements, in conjunction with Management team and Quality Management Group, in response to client and team feedback and quality auditsLook within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and ParexelFollow up departmental metrics, drive team members to meet departmental goalsParticipate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary

General Administration, Manage Personal Competencies and Role ModelingMaintain a working knowledge of, and assure compliance with applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPsMaintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective mannerPerforms a leadership role in ensuring managers and staff are communicating and coordinating efforts to provide superior line management services to staff. This must be achieved with consistency of approach and alignment across the managersDemonstrate excellent leadership skills within department, function or location. This includes taking an active role in, or leading departmental, functional or location/regional activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate

SkillsExcellent interpersonal, verbal, and written communication skills (including experience in making presentations at conferences, meetings, training sessions)A flexible attitude with respect to work assignments and new learningExcellent analytical and problem-solving skillsStrong computer knowledge including but not limited to Clinical Trial Management Systems(CTMS), Electronic Document Management System (EDMS), EDC, IWRS, and MS-OfficeGood experience in working in a matrix environment and value the importance of teamworkAbility to manage Managers and lead a global, “virtual” teamStrong ability to successfully manage a full workload across multiple and varied projects/tasks with enthusiasm and prioritize workload with attention to detailOutstanding negotiation, influencing and organizational skillsClient focused approach to workStrong ability to manage and motivate direct reports and wider team

Knowledge and ExperienceSignificant work experience including substantial management experience and knowledge in clinical research industry is requiredCRO experience required.CRA experience is requiredSignificant training experience is highly desiredFinancial management background is required

EducationEducated to degree level (biological science, pharmacy, or other health-related discipline required)

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