Operations Specialist Mgr - (R1038345) in Research Triangle Park, NC at IQVIA™

Date Posted: 11/11/2018

Job Snapshot

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.

Description

JOB DESCRIPTION
PURPOSE
Responsible for managing multiple operational deliverables across all service lines of varying scope size and indication within Operation Services. Recognized as specialist in one or more areas across Lifecycle Safety Services. Actively contribute to global Lifecycle Safety process initiatives and work in close collaboration with Lifecycle Safety Management (LSM) customer delivery management team and Lifecycle Safety Infrastructure regarding project/client initiatives.
RESPONSIBILITIES
 Provide leadership in the implementation of service operational initiatives; system requirements; client requests and electronic reporting.
 Provide technical and functional expertise across Lifecycle Safety services. Demonstrate a thorough understanding of various project protocol, therapeutic indications, budget and scope of work (SOW) across a myriad of projects; provide expertise and guidance in set up and maintain project files, standards, templates, electronic forums, databases and workflow.
 Provide historical perspective and input on client and process in collaboration with LSM. Communicate the successes or failures of previous initiatives and appropriately field concerns to customer delivery team and manager.
 Provide leadership to teams working in a matrix environment and coaching to junior staff.
 Promote sharing of ideas within teams to improve process efficiencies. Follow through effectively on actioned implementations.
 Ensure team is following standard best-in-class practices established by Lifecycle Safety Infrastructure.
 Establish ongoing and effective operational communications with LSM to ensure SO is providing high quality deliverables and meeting client expectations and to discuss general project status, milestones, Scope of Work, project issues etc.
 Work with LSM constructively in a matrix framework to achieve project and customer deliverables; proactively identifying issues and proposing solutions, providing them with technical support, functional expertise, identifying SOW changes and potential change orders, delegating client requests and implementation of new initiatives.
 Ensure financial project performance through oversight of key performance metrics (revenue, direct costs, time-sheet costs, utilization, and realization).
 Work with Lifecycle Safety LSM constructively in a matrix framework to achieve project and customer deliverables.
 Successfully implement and drive process initiatives, provide corresponding metrics to illustrate the productivity/profitability of new initiatives. Communicate confidently to the logistics and practicality of new processes.
 Ensure that a positive, collaborative team environment with project team members is maintained, encourage, motivate and lead by example, provide training and mentoring for project team members, customer delivery and operations staff, oversee allocation of team and project resource.
 Collaborate with operational team and managers to resolve performance related; staff efficiency; morale issues within teams.
 Ensure staff are trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs), FDA and ICH guidelines and regulations, Working Instructions and project instructions.
 Implement and support service operational decisions as determined and instructed by senior management.
 Participate in training across Lifecycle Safety service offerings. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies.
 Lead team to achieving departmental goals e.g. Utilization; realization and productivity metrics.
 Drive continuous process improvements.
 Perform other duties as assigned.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Extensive knowledge of Lifecycle Safety processes audit practices, governing safety legislation/regulation; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
 Extensive knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles SOPs, in depth knowledge and understanding of Lifecycle Safety processes; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
 Strong organizational skills and attention to quality compliance.
 Self-motivated driven and ability to work autonomously.
 Excellent presentation and customer-focused skills.
 Excellent mentoring and coaching skills.
 Strong project management and leadership skills.
 Excellent judgment, decision-making and problem solving skills.
 Encourage a flexible and receptive approach to changing demands.
 Demonstrate strong cooperative relationship with team and LSM.
 Excellent written and verbal communication skills, effective report writing skills.
 Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities.
 Ability to establish and maintain effective working relationships with coworkers, managers and clients.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 Bachelor's degree or educational equivalent in health science or other directly related field and 6 years' clinical research experience in a Contract Research Organization or Pharmaceutical company including 4 years of LS (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) experience or equivalent combination of education, training or experience.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled


We know that meaningful results require not only the right approach but also the 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™.



We know that meaningful results require not only the right approach but also the 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: R1038345