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Project Support Coordinator II
1 week ago
Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high quality standard. Brings up cases of variances (overburn/underburn). Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes. Exports and prepares study metrics reports. Maintains vendor trackers. Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager. When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.Job Qualification
Education
Bachelor's degree/High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.Knowledge, Skills, Abilities
Excellent command of English – verbal and written. Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems. Ability to work in a team or independently as required. Good organizational and time management skills as well as strong attention to detail with proven track record to handle multiple tasks efficiently and effectively. Flexibility and adaptability to provide efficient support while meeting tight project timelines. Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency. Proven ability to attain and maintain a good working knowledge of applicable Country Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout. Strong customer focus and good interpersonal skills. Effective oral and written communication skills.Physical Requirements / Work Environment
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an , ensuring you reach your potential.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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