Job Description

About the jobAt Thermo Fisher Scientific, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.Discover Impactful Work:As a Project Support Coordinator II, you will provide administrative and technical support to project teams including planning, organizing and coordinating responsibilities at a global level with supervision (as required) of the operational activities. You will assist with initial setup, ongoing maintenance of various systems, data entry completion and maintenance of database repositories. The role assists in preparing reports and data collection for analysis. You will also support audit readiness by ensuring files are reviewed on schedule, as detailed in the organization\'s SOPs/Client specific guidance document. You will support project documentation and systems by managing access requests, tracking project level documents and maintaining electronic trial master file audit readiness by conducting regular file reviews.Job Responsibilities:

• 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 QualificationEducation

• 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.

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