Clinical Operations Lead (RWE)

Job Overview
Independently  direct  the  execution  of  Real  World  studies  by  applying  clinical  research experience and decision making skills to proactively set goals and tangible expectations for project  team  members.  The  Site  Management  Lead  provides  leadership  of  the operations team, in support of the project leader, and in collaboration with the other functional teams, to achieve  the  delivery  of  the  project’s  overall  objectives  to  the  Sponsor’s  satisfaction  per contract  while  optimizing  speed,  quality  and  cost  of  delivery  and  in  accordance  with  our Standard Operating Procedures (SOPs), policies and practices.

Responsibilities Essential Functions•
Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed Start Up strategy. May implement and maintain the Regulatory Start Up Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Manage the operational aspects of projects to achieve “right subjects” and “right data” to meet our contractual requirements. May participate in bid defense preparations. May attend and present at bid defense presentations in partnership with business development and senior project leader as needed May develop, provide input, and maintain clinical project plans, including but not limited to i.e. Regulatory Start Up Management Plan, Clinical Operations Plan etc. to be incorporated into the integrated study management plan/project management plan. Real World Evidence Group resource request review and alignment from project award and during entire duration of the project. Accountable  for  the operational delivery  (site  activation, subject  recruitment,  site  management,  data  integrity)  of assigned portion of clinical studies, or may be fully accountable for less complex studies per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Partner with the project leaders to confirm objectives of the operations team according to agreed-upon contract, strategy and approach.  Effectively communicate and assess performance against these agreed objectives. Ensure or support ensuring, on less complex studies, that all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.
•Ensure  all  processes  and  tools  are  available  to  maximize  Site  Management  team’s  ability  to  monitor  and  secure  patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment.  Throughout the study these strategies and materials should be kept under constant review and updated in response to progress on the study to ensure clear understanding by all parties (internal and external) of expectations throughout  the recruitment period; and inspire customer confidence in a clear and enforced action plan and thereby ensure successful delivery to customer satisfaction.  •Monitor  progress  against  contract  and  prepare/present  project  information  proactively  to  all  stakeholders  internally  and externally as required. Deliver  the  project/program  according  to  the  quality  management  plan.  Guide  Site Managers/Clinical  Research  Associates (CRAs) and advise on critical specific study issues. Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies.  Partner with functional leaders in problem solving and resolution efforts. Achieve project quality by identifying quality risks and issues, responding to issues raised by Site Management team members and planning/implementing appropriate corrective and preventative action plans. Serve as clinical project contact with customer where applicable and agreed with the project leader. Drive  for  high  performance  and  efficiency  of the operations team  through  Site  Manager/Clinical  Research  Associate  (CRA) project objectives including the conduct of monitoring visits. Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Support the project leader and accountable as functional lead, in ensuring the financial success of the project. Ensure  accurate  completion  and  maintenance  of  internal  systems  (with  emphasis  on  Clinical  Trial  Management  System), databases, tracking tools, timelines and project plans with project specific information. Identify changes in scope and support project leader in completion of the change control process. Identify lessons learned and implement best practices. Adopt corporate initiatives and changes and serve as a change advocate when necessary. Provide input to line managers of their project team members’ performance relative to project tasks. May Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. May mentor and coach colleagues as required and provide technical guidance both within and outside the project.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.