Director, FSP Clinical Operations

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Project Delivery Management and Oversight

• Strategize and oversee team and departmental activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables. Ensure production of accurate and efficient resourcing plans in conjunction with appropriate stakeholders
• Act as executive oversight of a large project where applicable

Performance Management, Staff Development and Talent Management

• Provide technical support to team members and managers to ensure that they have the required knowledge to fulfill their duties
• Ensure direct reports drive 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 remedial action
• Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team
• Undertake 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/objective. Drive training needs development in collaboration with appropriate learning and development organization to ensure availability of appropriate training. Ensure departmental or functional training plans are in place and appropriate
• 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 measures
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales
• Work with senior departmental management in developing managers and ensuring a talented pipeline of management staff within the department or function

Client Management and Business Development

• Strategize and drive efforts for generating business leads (client networking, public speaking, etc.). Support proposal review for clinical sections.
• Participate in and contribute to project bids, including client presentations. Provide on-going support to the Commercial organization
• Act as the client contact for local business when required
• Take appropriate action following regular feedback sessions from client’s technical groups

General Operations and Functional/Business Unit Management

• Participate in, champion or lead PAREXEL and department system/standards improvement activities or committees, task force groups as needed, including change management
• Ensure agreed levels of productivity/billability and staff turnover are maintained on a regional or departmental basis
• Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Ensure compliance with travel and billability guidelines for department, region or function, are met where appropriate. Travel as needed.
• Lead the management team to ensure that resources (processes, procedures, personnel, etc.) optimally support the business requirements of the function and approve exhibit resourcing for department or function
• Ensure implementation of process improvements in response to client and team feedback and quality audits
• Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and PAREXEL
• May manage multiple countries, sub-region/s and/or subcontractors
• Ensure departmental and company metrics are met
• Participate in or Lead departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• Ensure that the department has a well-organized infrastructure and adequate resources to enable projects to be completed on time and within budget.
• Provide accurate forecasting figures for the annual budgeting process and manage throughout the year to ensure that the budgetary goals are met or exceeded.
• Implement a global strategy according to regional conditions
• Responsible for regional non - labor and labor cost budget.

General Administration, Manage Personal Competencies and Role Modelling

• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL SOPs
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Performs 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 managers. May serve as GMBA for a location or country
• Demonstrate excellent leadership skills within department, function or geography. This includes taking an active role in, or leading departmental, functional or regional/global activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate

Skills:

• Excellent 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 learning
• Excellent analytical and problem-solving skills
• Strong computing knowledge including but not limited to the Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), EDC, IWRS, and MS-Office products such as Excel and Word
• Good experience in leading in a matrix environment and value the importance of teamwork
• Advanced ability and demonstrated strength in managing Managers and leading diverse teams
• Advanced ability to successfully manage a full workload across multiple and varied projects/tasks with enthusiasm and prioritize workload with attention to detail
• Outstanding negotiation, influencing and organizational skills
• Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer.
• Advanced ability to manage and motivate direct reports and wider team.
• Knowledge of the International pharmaceutical market and the services required by sales, marketing and operational support to achieve product success
• An ability to assess situations and make and carry through difficult decisions
• Broad therapeutic understanding

Language Skills:

• Competent in written and oral English and local language

Knowledge and Experience:

• Significant work experience including substantial management experience and knowledge in clinical research industry

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience