AD Clinic Operations Phase I

Role Summary: Manages the day-to-day activities of the clinical and technical operations staff in the phase I clinic including logistical and operational planning for all projects being conducted in the phase I clinic and oversight of the management of the clinical staff. Essential Functions: Plans for the appropriate study conduction coordination and staffing logistics to ensure a successful weekly phase I work flow including volunteer recruitment, clinical conduction, and client deliverables. Assures appropriate and adequate staffing of the clinical and technical operation units. Attends regular standing meetings and key sponsor initiation meetings, as well as schedules operational and study meetings as needed. Participates in meetings with Clinics upper management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager and supervisor detailing the workload ahead and retrospectively looking at past events and determining our clinic’s abilities to meet future study and sponsor needs. Communicates with client representatives on a regular basis to gain feedback on our clinical operations. Participates in and leads work teams in automation to further competitive advantage and utilize technological advances which will strengthen operations. Regularly participates in weekend coverage as it relates to management oversight of the phase I clinic and is available for client dinners and entertainment opportunities as needed. Performs other study-related duties as qualified by documented training. Management Role: Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large centralized staff function. 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. Role Summary: Manages the day-to-day activities of the clinical and technical operations staff in the phase I clinic including logistical and operational planning for all projects being conducted in the phase I clinic and oversight of the management of the clinical staff. Essential Functions: Plans for the appropriate study conduction coordination and staffing logistics to ensure a successful weekly phase I work flow including volunteer recruitment, clinical conduction, and client deliverables. Assures appropriate and adequate staffing of the clinical and technical operation units. Attends regular standing meetings and key sponsor initiation meetings, as well as schedules operational and study meetings as needed. Participates in meetings with Clinics upper management to provide updates, receive feedback, discuss strategic business plans, etc. Initiates and participates in weekly meetings with each department manager and supervisor detailing the workload ahead and retrospectively looking at past events and determining our clinic’s abilities to meet future study and sponsor needs. Communicates with client representatives on a regular basis to gain feedback on our clinical operations. Participates in and leads work teams in automation to further competitive advantage and utilize technological advances which will strengthen operations. Regularly participates in weekend coverage as it relates to management oversight of the phase I clinic and is available for client dinners and entertainment opportunities as needed. Performs other study-related duties as qualified by documented training. Management Role: Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large centralized staff function. 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.

Education and Experience: Bachelor's degree in business or health-related field 6-10 years of clinical research experience specific to the areas of Phase I, clinical operations, and/or regulatory, medical affairs, or safety and/ or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education, training, & experience 3-5 years of supervisory/management experience Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities: Extensive experience in conducting clinical trials as well as overseeing and leading the efforts of others involved in conducting clinical trials Ability to work on multiple projects at one time Strong management skills are essential for this position Excellent verbal and written communication skills Ability to interact professionally with different levels of staff, management, and clients Ability to address sponsor concerns Ability and willingness to travel and visit pharmaceutical and biotech clients as well as attend industry trade shows Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Physical Requirements: Frequently 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. Moderate mobility required. Occasional crouching, stooping, 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 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.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Education and Experience: Bachelor's degree in business or health-related field 6-10 years of clinical research experience specific to the areas of Phase I, clinical operations, and/or regulatory, medical affairs, or safety and/ or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education, training, & experience 3-5 years of supervisory/management experience Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities: Extensive experience in conducting clinical trials as well as overseeing and leading the efforts of others involved in conducting clinical trials Ability to work on multiple projects at one time Strong management skills are essential for this position Excellent verbal and written communication skills Ability to interact professionally with different levels of staff, management, and clients Ability to address sponsor concerns Ability and willingness to travel and visit pharmaceutical and biotech clients as well as attend industry trade shows Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Physical Requirements: Frequently 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. Moderate mobility required. Occasional crouching, stooping, 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 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.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.