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Jobs in Malaysia   »   Jobs in Malaysia   »   Education / Training jobs   »   Associate Clinical Research Manager

Associate Clinical Research Manager

The Sr. Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.

Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects. Required to travel 60-80% on average.

Education and Experience:Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institutionPrevious experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilitiesValid Driver's License where applicableIn some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be consideredKnowledge, Skills and Abilities:Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating ProceduresEffective oral and written communication skills, with the ability to communicate effectively with medical personnelStrong customer focusEffective interpersonal skillsStrong attention to detailEffective organizational and time management skillsProven flexibility and adaptabilityAbility to work in a team or independently as requiredGood computer skills: good knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsWorking ConditionsWork is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.Physical DemandsAbility to work in an upright and /or stationary position 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. Occasional crouching, stooping, with 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 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 to obtain or relate information to diverse groups. 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.
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