Director Clinical Operations

Summarized Purpose:
Provides strategic direction, leadership and management within an area of a region to secure the successful completion of clinical deliverables within assigned studies. This includes training and management of staff to contribute to the successful delivery of clean data from evaluable patients within project parameters of time, quality, and cost. Provides direct supervision, support, training and mentoring to their staff regarding all general aspects of the CTM and Clinical Manager roles. Will be responsible for performance assessments and annual review of their direct reports. Assists in resource utilization, policy development and implementation of goals by working with leadership in all functional areas on the continuous development of business processes to support crossfunctional teams ensuring work is uniform, complete and managed appropriately within assigned functional area. In developing regions, responsibilities may include oversight of all deliverables within a country/region including participation in business development activities.

Essential Functions
• Supervises and coordinates departmental functions, including mentoring
managers in day-to-day activities and responsibilities related to the clinical
deliverables. Ensures the clinical teams are provided with the necessary support and resources to successfully deliver clinical deliverables, e.g., oversees study start-up, monitoring and site management deliverables. At a country level, may liaise with other functional departments to ensure delivery of projects to clients and contribute to feasibility projects
• Ensures the timely execution of clinical deliverables with a focus on quality
deliverables. In those cases, develops and drives the specific and overall project
or program strategies to ensure optimum performance and achievement of
annual plans and targets. Facilitates meetings to identify potential risks and
work with the clinical team to develop and communicate contingency plans.
Ensures risks to clinical deliverables and potential solutions are communicated
through appropriate escalation pathways. Reviews and assesses clinical project or program finances and ensures risks are escalated appropriately with any information necessary for a contract modification
• Manages department resource levels including hiring and promoting, as
appropriate. Participates in resource calls and ensure teams are provided with
adequate levels of appropriately qualified resources
• Inducts new managers to PPD. Provides performance appraisals, evaluate and
allocate bonuses and merit increases, as appropriate. Develops and motivates
through goal setting, ongoing feedback, formal evaluation, and effective
delegation of decision making. Ensures staff is trained and mentored according
to company policies and procedures. Develops, implements and reviews key
performance metrics
• Manages the overall budgeting activity of the assigned group(s) - annual and
long range forecast
• Participates in global and/or cross-functional initiatives and process improvement projects

Policy & Strategy
Establishes policies appropriate for the function. Interprets and recommends
modifications to company-wide policies and practices. Develops and is responsible for budgets, schedules, and performance standards.

Freedom to Act

Objectives are defined in collaboration with senior management and results assessed from a relatively long-term perspective.

Liaison

Interacts with senior management, and others concerning matters of significance to the company. Conducts business and technical briefings for senior and top management and for external management and / or representatives.

Qualifications:

Education and Experience:
• Bachelor's Degree in a science related field.
• Significant clinical research experience (comparable to 12+ years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
• Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
• Strong leadership skills.
• Valid Driver's License.
• Valid Passport.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Advanced leadership and management skills
• Excellent judgment and decision making skills
• Excellent interpersonal and problem solving ability
• Expertise in negotiating and strong organizational skills
• Excellent oral/presentation and written communication skills in the native language and in English
• Ability to perform tasks required of a functional staff
• Ability to successfully network with other Divisions (departments) where necessary
• Strong knowledge of budgeting, forecasting and fiscal management
• Demonstrated expertise in leading, motivating and integrating project teams
• Self-motivated and possess good interpersonal skills and projects a positive attitude
• Ability to effectively teach required skills
• Excellent coaching and mentoring skills
• Knowledge and understanding of clinical development regulatory guidelines and Directives
• Ability to work effectively in a matrix organization

Management Role:
Directs through lower management levels. Has responsibility for managing a function that includes
multiple related departments. In some instances may be responsible for a functional area (as determined
by executive management) and not have subordinate supervisors or employees. May manage employees
across multiple regions.

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