Manage the administrative support across all Lifecycle Safety service lines to the SO and LSM functions as appropriate.
Provide support to junior administrative team members.
Essential Functions Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events (AE) / endpoint information, determining initial / update status of incoming events, tracking timelines for completion of event processing, distributing event information to appropriate project personnel in the workflow for continued processing, review and preparation of endpoint documentation, transfer of events to client and other parties as identified by operations lead, obtaining confirmation of report receipt and track submission and assuming workflow responsibilities for various projects.
May assist with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with deadline quality measurements, as directed by operations team member or manager.
Assist with administrative team support e.g.
project start-up tasks, creation and maintenance of project files, systems access requests, periodic distribution of AE listings, and shipping of information supplies to sites as directed by senior operations team member.
May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization holders, investigators, customers and operations team in accordance with deadlines, perform project administrative tasks such as creation of labels using investigator list, maintenance of personal safety files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking and filing of submission dossiers, and distributing listings to client and / or operations team members.
Creating, maintain and track case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications / systems as directed.
Archiving case folders and project files after event closure, coordination of transfer of archived material to company / customer archive storage facilities after study closure, assisting in creation of records management processes and procedures, providing key input to operations team on acquisition and / or upgrade of records management application / systems and serving as liaison between Lifecycle Safety department and records management department.
May assist with system support tasks such as utilizing design specifications, study form, and protocol to create project specific entry specifications and annotated project forms for database under guidance from operations lead and / or manager, creating project tracking spreadsheets and associated tracking entry specifications, assisting in database validation through performance of user testing, performing ad hoc database searches for operations team leads, assisting operations team member in assessing database setup needs, assist with project phone / fax line set-up as required, escalating any system / equipment problem.
Oversee and co-ordinate administrative support by coordinating team / department / customer / project oversight group meetings, coordinating stationery orders, dispatching documents via courier services, reserving meeting rooms and IT equipment, and providing administrative support where required.
Identify and record process or quality problems and bring them to the attention of a senior team member.
Provide training / mentoring to new / less experienced staff.
Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and / or case processing.
Co-ordinate, oversee and delegate resource tasks to administrative team members as appropriate and monitor the intake of cases and archiving process when multiple coordinators are involved.
Involvement and contribution in local / global department committees Perform other duties as assigned.
Qualifications Scientific or healthcare discipline or allied life sciences 1 year relevant work experience.
Or equivalent combination of education, training and experience.
Good understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Standard Operating Procedures (SOPs) and work instructions applicable to the role.
Good working knowledge of Microsoft Office and web-based applications.
Good knowledge of medical terminology.
Strong organizational skills and time management skills.
Strong verbal / written communication skills.
Self-motivated and flexible.
Excellent attention to detail and accuracy.
Ability to follow instructions / guidelines, utilize initiative and work independently.
Proven ability to multi-task, manage competing priorities and deadlines.
Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
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