Safety Associate

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Description de l'emploi

• Work with relevant teams to ensure accuracy and functionality of – and appropriate access to – websites and collaborative areas/databases and documents that form a key resource for the Global Safety organisation
• Provide support compiling agendas, coordinating meetings, capturing and filing meeting minutes, relevant of study documents and communications and providing support to support the study leads and scientists.
• Support effective communication within and outside the department by reformatting information provided by subject matter experts
• Maintain an awareness and be an early adopter of new technology to select the most appropriate application for a given purpose
• Manage and triage group mailboxes as necessary
• Provide administrative support on new hire onboarding
• Contribute to process improvement activities and provide technical support for the department processes as needed
• Assist with document review: Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs) and completion of start-up/close out checklists completion under the supervision of the study lead
• Assist with the monitoring of KPIs, training compliance etc.
• Support study audit & inspection activities, coordinating the collation of audit/inspection request documents by uploading and reconciling documents provided against the requests
• Implement a standardized filing structure (i.e. table of contents) and naming conventions within JIRA, including the maintenance of JIRA; provides consistency across all studies and ensures accurate and thorough documentation of all study activities performed by the team

Profil

• Life Sciences Degree
• 3-4 years of experience providing technical support for a high volume medically oriented or Clinical R&D department in a large corporation.
• Familiarity with MS Office tools, document management systems
• Excellent organisational skills and attention to detail
• Ability and willingness to proactively communicate with stakeholders to understand needs and be responsive to requests 
• Excellent written & verbal communication skills, with demonstrated ability to interact well at all levels of the organisation. Proficient in English.
• Ability to effectively handle and appropriately escalate issues in a timely manner based on risk
• Awareness of PV processes and ability to develop, document, communicate and oversee processes
• Awareness of process improvement techniques and ability to analyze performance metrics to drive continuous improvement