The Clinical Mgr-Quality role is mainly responsible for below work:
1)
Set up quality plan in country level and study
level based on internal risk assessment on project/sites and conduct quality
activities which including the onsite quality visits as well as inhouse
quality.

2)
Support NMPA inspection, provide consulting to
project team, support onsite inspections as needed

3)
Delivery the quality improvement training to
clinical operation team per the quality visits observations. Provide effective
coaching and training to achieve and improve quality needs at project, country
and site level.

4)
Provide advice and support to operational team in
improving compliance with GCP, SOPs and applicable regulatory requirements and
guidelines

5)
Oversight and Lead the Quality Specialist to
perform quality related activities

Qualifications: Education and Experience: Bachelor's Degree in a life science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. In some cases, an equivalent combination of education, professional training and experience that provides the required knowledge, skills and abilities may be considered.Significant clinical research experience (comparable to 5+ 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.Valid Driver's License and Passport.Knowledge, Skills and Abilities: Excellent mentoring/leadership/supervisory skillsAdvanced knowledge of clinical trials monitoring; Remote and on-siteDemonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)Demonstrated ability to evaluate medical research dataStrong organizational and negotiation skillsStrong attention to detailEffective written and oral communication skillsGood knowledge of English language and grammarCompetent use of computer to include data entry, archival and retrievalAbility to travel as neededExcellent team player with team building skillsExcellent interpersonal and conflict resolution skillsAbility to utilize problem-solving techniques applicable to constantly changing environmentSolid knowledge of medical/therapeutic areas and medical terminologyManagement Role: Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.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.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.

Additional Information

Requisition ID: 160031
Additional Information

Requisition ID: 160031