Centralized Monitoring Dir

Job Family Description:

Candidates with programming, technical and data focused backgrounds that can support with the implementation of solutions for ongoing issues currently being resolved on a study-by-study basis normally via excel. This would be a billable role with hours being provided for the resource from under CM support role.

A technical leadership role that drives adoptions and customization of operational tech tools and support to move to a more digital way of working aligned with the DCOM strategy. Able to lead/oversight to the overall clinical tech set-up and more readily provide solutions to the available data to resolve issues across our portfolio. Able to ensure that long term solutions are put in place that need little or no manual intervention and that requirements are shared with IT for permanent solutions.

JOB OVERVIEWJob Profile Summary    Apply technical expertise to support central monitors in their pursuit to effectively manage  projects inclusive of set-up and execution of tasks directly impacting the operational success of the team.   ectors are an integral part of clinical trial delivery, leading and working alongside centralized monitoring teams to improve patients’ lives by bringing new drugs to the market faster. Ensures all work is in accordance with SOPs, policies, and practices.  Sustain and improve the commitment to being the center for operational productivity measurement, optimization, and efficiency through digital and technical change and improvement increasing value-add throughout the organization.

Responsibilities

Essential Functions

•    Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedure (SOPs), project plans).•    Extensive knowledge of reporting, data analytics and clinical trials design. •    Expert with computer based tools / systems / technology.•    Work strategically to realize clinical project goals including setting and developing digital and technical clinical strategies.•    Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.•    Knowledge of clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and support delivery plan comparisons and the ability to identify additional service opportunities or out of scope work.•    Collaborate with the centralized monitoring team to support milestone achievements. Support the ability to digitally report to internal and external stakeholders as per project scope requirements.•    Support professional development by providing feedback to centralized monitoring team line managers on performance relative to project tasks.•    Recommend strategic programs forming long-term business partnerships maximizing the creation of global solutions that accelerate operational process/productivity improvements within IQVIA positively impacting data capture, project planning, change/data/process management, data compilation and high quality deliverable generation.•    Participate in strategic meetings and focus teams serving as advisor while gathering potential initiative insight for future engagement.•    Identify and drive system enhancement and implementation for internal system/tools.•    In conjunction with senior/executive management actively support the determination of initiative structure providing leadership regarding the scope and types of initiatives appropriate for team involvement.•    Determine initiative scope, timelines, and feasibility.•    Evaluate and provide feedback regarding risks, quality, and overall probability of success minimizing negative impact on project objectives and deliverables.•    Develop risk management plan including coordination of issue escalation and resolution as well as contingency plans to mitigate risks across initiatives.•    Serve as knowledge and subject matter expert for service area and contact for senior and executive management regarding initiatives.•    Ensure initiatives are aligned with overall strategy ensuring alignment and incorporation with overall IQVIA strategy•    Identify and establish transparent, successful collaboration with internal and external stakeholders: team, client and IQVIA•    Lead high level presentations to senior and executive management.    Provide user input on IT needs necessary to support all aspects of Risk Based Monitoring.  MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.ExperienceTypically requires 7 - 10 years of prior relevant experience.KnowledgeRequires extensive knowledge of multiple job areas obtained through advanced education and experience.Viewed as a leading expert within the field by peers.EducationBachelor's Degree - Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification