PV Coordinator

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement reputed company, prepare contractual documents, coordinate and facilitate meetings and accurately manage reputed company incoming safety documentation. What You’ll Do: Coordinates the reputed company review of protocol inquiries, serious and non-serious adverse events, diagnostics; tracks reputed company necessary data and generates reports for the reputed company, project team and/or external vendors. Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to reputed company portals and distributes to reputed company project teams. Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit reputed company. Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data reputed company. Performs data entry into internal/external databases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negatively reputed company project timelines. Oversees expenses and manages translations; ensuring budget parameters are not exceeded. Coordinates department functions and performs other duties as assigned. Supports any specific activities performed by the local office, which cannot be performed from elsewhere Education and Experience Requirements: High / Secondary school diploma or equivalent and relevant formal reputed company / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to at least 4 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Ability to assist in the management of a large project and to reputed company work direction and training to other safety support staff working on the project Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environments Ability to work independently with minimal supervision, demonstrating initiative Ability to build strong relationships Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Ability to reputed company as a reputed company and communicate respectfully and diplomatically with reputed company clients, management, project team members and other internal staff Self-motivated, reputed company attitude with effective oral and written communication and interpersonal skills Excellent computer skills to include MS Office (Word, reputed company, PowerPoint, reputed company) Ability to identify and set priorities and effectively reputed company a reputed company of tasks simultaneously with strict deadlines Strong attention to detail and accuracy with orientation toward careful and meticulous work Ability to maintain a reputed company and reputed company demeanor in challenging circumstances Flexibility to reprioritize workload to meet changing project timelines Demonstrated ability to reputed company and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/reputed company SOPs and WPDs for reputed company non clinical/clinical aspects of project implementation, execution and closeout Working Conditions and Environment: Work is performed in a homebased environment with exposure to electrical office equipment Potential drives to site locations and/or travel required on rare occasion reputed company of work computer-based Long varied hours required on occasion Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job