Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Summarized Purpose:

Oversees daily line management responsibilities of assigned team. Serves as positive leadership and professional role model for all clinical administration staff providing direct coaching and development support to their operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for all clinical administration staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus will be on line and performance management of team members. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions and Other Job Information:

Essential Functions

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Oversees all department initiatives are implemented to ensure efficiency in proposed processes, consistency in execution and quality output.
• Develops and implements Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs). Develops and implements training processes for staff. Implements project- specific training activities for research staff, including mentoring of new team
• members including other management staff.
• Performs any other duties and projects as assigned by management.

Policy &

Strategy

Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility.

Freedom to Act

Assignments are task or activity oriented. Work is reviewed for soundness of judgment and overall quality and efficiency. A portion of the time may be spent performing individual tasks.

Liaison

Interacts internally primarily with subordinates and other supervisors. External interaction is typically with suppliers, vendors, and / or primary customers. Primary purpose of liaison is information sharing and basic problem resolution.

Qualifications:

Education and Experience:

Bachelor's Degree in a life science related field or equivalent and relevant formal academic / vocational qualification.

Significant clinical research experience (comparable to 0 - 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out. 1+ year of leadership responsibility

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

• Demonstrated ability to attain and maintain a good working knowledge of ICH GCP, applicable regulations and PPD/Client procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
• Strong knowledge in all phases of clinical trials, specifically study start-up, study maintenance and study close-out
• Skilled in managing, motivating and mentoring staff
• Ability to analyze and manage clinical administration portion of Business Development bids and contracts for multiple studies within specific division(s)/office(s)
• Knowledge of budgets, projects and metrics
• Ability to handle multiple tasks simultaneously, to meet rigorous timelines and to work effectively in stressful situations
• Excellent organization skills and strong attention to detail
• Excellent communication and interpersonal skills
• Ability to travel if required

Management Role:

Directly supervises individual contributors, administrative support and / or entry-level professionals.

Working Conditions and Environment:

• Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Travel varies (more for some individuals), which includes frequent drives to site locations and domestic travel and rare international travel where applicable
• Personal protective equipment required such as protective eyewear, garments and gloves in some instances.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Frequently vertical and /or stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Percent Billable:

0% - 20%