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Assoc Mgr, Safety Opns Team (R1056081)

Posted: 2019-05-17

Industry
Hospitals/Healthcare/Diagnostics
Function
IT
Role
Software Engineer/ Programmer
Posted On
17th May 2019
Job Ref code
J3M3MS65FDZ8418168G
Job Description


Job Description

Join us on our exciting journey!IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
PURPOSE
Lead large (over 500 adverse events (AEs)/endpoints) and/or multiple global clinical or post marketing projects ensuring all
activities are completed on-time, within budget and meet quality standards. Obtain and process AE/ICSR/endpoint data
obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating
procedures (SOPs), and project requirements.
RESPONSIBILITIES
Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned
projects; set up and maintain project materials such as project files, forms, templates, databases and workflow.
Build a positive, collaborative team environment with project team members; provide training and mentoring for project
team members and department staff; assist management with allocating resources to projects.
Establish and maintain effective project communications by representing department at interdepartmental project team
meetings, investigator meetings, and client meetings and by conducting productive internal department project team
meetings; provide global coordination of departmental activities.
Participate in client and internal audits for assigned projects. Liaise with Quality Assurance staff and overall management
in the compilation of CAPs.
Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend and
represent assigned projects at financial meetings.
Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent
feedback to department managers on staff quality and progression.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client
requests or concerns; participate in project review meetings with management; communicate and document project
issues to project team members and department management in a timely manner; complete regulatory reports.
Drive case follow-up and closure processes; process cases as needed.
Assist senior leaders in managing department by identifying, developing and implementing new processes and systems
designed to improve quality and efficiency, updating managers on new regulations, representing department at sales,
marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions
(WIs).
Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projects
according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and post
marketing areas
In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical
Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
In-depth knowledge of departmental standard operating procedures (SOPs)
Skill in use of multiple safety databases
JOB DESCRIPTION
Strong project management skills
Strong coaching skills
Strong team building skills
Excellent written communication skills
Ability to lead projects within strict deadlines
Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients
and regulatory agency representatives
Ability to establish and maintain effective working relationships with coworkers, managers and clients
We know that meaningful results require not only the right approach but alsothe right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA

Job ID: R1056081



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